DDP LIST AS OF APRIL Edited APRIL 1 04apr2022

GUIDE TO MEDICAL / PARAMEDICAL PRACTITIONERS
LIST OF DANGEROUS DRUG PREPARATIONS (DDPs)
ACQUISITION / DISPENSING / PRESCRIBING:
To be purchased through an approved Local Order Permit (FM-CSVlrd-09). To be prescribed and dispensed through
the DOH Special Prescription Form for Dangerous Drugs. Only one (1) dangerous drug preparation shall be
prescribed in one single prescription form. Partial filling allowed. STRICTLY NO REFILL.
RECORDING / REPORTING:
To be recorded in an appropriate Dangerous Drugs Register in accordance with the PDEA-prescribed format. To
submit semi-annual report not later than January 15 and July 15 of each year.
LICENSE REQUIRED:
Prescribing Physician / Dentist / Veterinarian S2 License
Retail Dealer of DDPs S3 License
Wholesaler Dealer of DDPs S4 License
Manufacturer / Repacker of DDPs S5-C License
Importer of DDPs S5-I License
Exporter of DDPs S5-E License
Dangerous Drug Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)
* ALTROX M: Torrent Pharmaceuticals Ltd,
ALPRAZOLAM 250mcg Tablet India
Blister 10s, Box 100s
FDA Reg. No.: DRP 3132 I/D: Torrent Pharma Philippines,
Valid until 11 APRIL 2026 Inc
* ALTROX
500mcg Tablet
FDA Reg. No.: DRP 3180
Valid until 26 JUNE 2026
* AXAL M: Amson Vaccines and Pharma

250mcg Tablet (Pvt), Ltd, Pakistan
FDA Reg. No.: DR-XY 38992 I/D: Sahar International Trading
Valid until 27 JAN 2026 Corp.
* AXAL
500mcg Tablet
FDA Reg. No.: DR-XY38855
Valid until 27 JAN 2026
* AXAL
1mg Tablet
FDA Reg. No.: DR-XY 38993
Valid until 27 JAN 2026
* SERELAM M: General Pharmaceuticals
250mcg Tablet Limited, Bangladesh
FDA Reg No. DRP-5103 I/D: Ambica International
Valid until 12 FEB 2024 Corporation
* XANOR M: Sanico NV, Belgium

250mcg Tablet
Blister 10s Box 100s I: PF OFG Philippines, Inc.
FDA Reg. No.: DRP-2146
Valid until 20 NOV 2023
Page 1 / 15/fybt/April 1, 2022

* XANOR
500mcg Tablet M: Pfizer Pharmaceuticals LLC,
Blister 10s Box 100s Puerto Rico
FDA Reg. No.: DR-XY 14607
Valid until 21 MAR 2025 I: PF OFG Philippines, Inc.
* XANOR XR
500mcg Controlled Release Tablet M: Pfizer Italia S.R.L, Italy
Blister 10s Box 100s
FDA Reg. No.: DRP-2048 I: PF OFG Philippines, Inc.
Valid until 4 MAY 2023
* XANOR
1mg Tablet
Blister 10s Box 100s M: Pfizer Pharmaceuticals LLC,
FDA Reg. No.: DR-XY16774 Puerto Rico
Valid until 21 MAR 2025
I: PF OFG Philippines, Inc.
* ZOLDAC 0.25 M: Cadila Healthcare Limited,

250mcg Tablet India
Blister 10s, Box of 30s
FDA Reg. No.: DRP-7245 I/D: Zydus Healthcare Philippines,
Valid until 16 JUN 2026 Inc.
* ZOLDAC 0.5
500mcg Tablet
* ZOLGEN M: Lloyd Laboratories Inc.,

500mcg Tablet Bulacan
T: Innogen Pharmaceuticals, Inc
FDA Reg No.: DR-XY 39552
* LEXOTAN M: Delpharm Milano SRL, Italy

BROMAZEPAM 1.5mg Tablet
Blister 10s, Box 100s I/D: Zuellig Pharma Corporation,
FDA Reg No: DR-XY40440 Paranaque
Valid until 22 DEC 2026
** NORSPAN M: LTS Lohmann Therapie-

BUPRENORPHINE 5mg Transdermal Patch Systeme AG, Germany
Box 2s
FDA Reg. No. DR-XY35292 I/D: Mundipharma Distribution
Valid until 24 NOV 2025 GmbH (Philippine Branch)
** NORSPAN
10mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35290
** NORSPAN
20mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35291
** TRANSTEC
20mg (35mcg/h) Transdermal Patch
Box 1s, 2s, 4s
FDA Reg. No: DR-XY 46026
Valid until 8 SEPT 2022

** TRANSTEC M: LTS Lohmann Therapie-
30mg (52.5mcg/h) Transdermal Patch Systeme AG, Germany
Box 1s, 2s, 4s
BUPRENORPHINE FDA Reg. No: DR-XY 46027 I/D: Mundipharma Distribution
Valid until 8 SEPT 2022 GmbH (Philippine Branch)
* CLONOTRIL-0.5 M : Torrent Pharmaceuticals Ltd.,

CLONAZEPAM 500mcg (0.5mg) Tablet India
FDA Reg No: DRP-2810 I/D: Torrent Pharma Philippines.,
Valid until 29 AUG 2023 Inc.
* CLONOTRIL-2
2mg Tablet
FDA Reg No: DRP-2809
Valid until 02 SEP 2023
* EPILINE 2 M: Cadila Healthcare Limited,

2mg Tablet India
Blister 10s
FDA Reg No: DRP-7185 I/D: Zydus Healthcare Philippines,
Valid until 27 MAY 2025 Inc,
* RIVOTRIL M: Recipharm Leganes S.L.U,

2mg Tablet Spain
Bottle 100s
FDA Reg. No. DR-XY37012 I: Roche (Philippines), Inc
D: Zuellig Pharma Corporation,
Paranaque
* ZEPACLON M: Remedica Ltd, Cyprus
2mg Tablet
Blister 10s, Box 30s I/D: Ambica International
FDA Reg. No. DRP-9038 Corporation
* TRANXENE M: Sanofi-Aventis, S.A , Spain

CLORAZEPATE 5mg Capsules
DIPOTASSIUM Blister 10s, Box 30s I: Sanofi-Aventis, Philippines, Inc
FDA Reg. No. DR-X1254
Valid until 14 OCT 2022 R: Hizon Laboratories, Inc.
ANXIOL M: Tai Yu Chemical &

DIAZEPAM 5mg/ml, 2ml Ampule Pharmaceutical Co., Ltd, Taiwan
Box 10s
FDA Reg. No. DR-XY29833 I/D: Endure Medical Inc.,
Valid until 9 AUG 2022
ANXOL M: Ciron Drugs &

5mg/ml (10mg/2ml) Ampule Pharmaceuticals PVT Ltd, India
Box 10s
FDA Reg No DRP-4175 I/D: Ambica International
Valid until 16 DEC 2024 Corporation
LORCAM M: T.P Drug Laboratories (1969)

5mg/ml, (10mg/2ml) Ampule Co, Ltd, Thailand
Box 50s
FDA Reg. No. DR-XY22760-B I / D: Lordla Pharma Sales
* PAMIZEP M: Shine Pharmaceuticals

5mg tablet Limited, India
FDA Reg. No. DR-XY38635 I/D: Endure Medical, Inc.
Valid until 15 October 2025

DIAZEPAM TRANKIL M: Rotexmedica, GmbH,
5mg/mL, (10mg/2ml) Ampule Germany
Box 10s
FDA Reg. No. DRP- 8331 I/R/D: Duopharma Trade
Valid until 03 SEP 2024 Philippines, Inc
VALIUM M: Recipharm Leganes, S.L.U,

5mg/mL, (10mg/2ml) Ampule Spain
Box 10s
FDA Reg No. DR-6298 I: Roche (Philippines), Inc.,
Valid until 14 APR 2023
* VALIUM
5mg Tablet
FDA Reg. No. DR-XY37749
valid until 30 JAN 2025
* VALIUM
10mg Tablet
VALZEPAM M: L.B.S Laboratory Ltd, Part.,

5mg/ml Solution for Injection (IM/IV) Thailand
2 ml Amber colored Ampule, Box of 50’s
I/D: Phil Pharmawealth, Inc.
* VEXEPAM M: Mercury Laboratories Ltd,

5mg Tablet India
FDA Reg No. DR-XY41080 I/D: Phil Pharmawealth, Inc.
Valid until 26 JULY 2022
* VEXEPAM
10mg Tablet
FDA Reg No. DR-XY41081
EPHEDRINE SULFATE M: Hizon Laboratories, Inc.,

EPHEDRINE 50mg/mL, 1mL Ampule Antipolo, Rizal
Box 100s
FDA Reg No. DR-4468
Valid until 21 FEB 2023
FEDRIN M: Geofman Pharmaceuticals,

30mg/mL, 1mL Ampule Pakistan
Box 5’s
FDA Reg No. DR-XY41068 I/D: Sahar International Trading,
Valid until 18 JULY 2022 Inc
ABSTRAL M: Aesica Queensborough Ltd,

FENTANYL 100mcg Sublingual Tablet United Kingdom
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45371 T: A. Menarini Philippines, Inc.
ABSTRAL
200mcg Sublingual Tablet
ABSTRAL

ABSTRAL
FENTANYL 600mcg Sublingual Tablet
Status: on-going renewal. Filed on 22 APR 2021
ABSTRAL
Status: on-going renewal. Filed on 22 APR 2021
DUROGESIC D-TRANS M: Janssen Pharmaceutics NV,
12mcg/hr Transdermal Patch Belgium
Box 5s
FDA Reg No. DR-XY33326 I: Johnson & Johnson
Valid until 29 DEC 2025 (Philippines), Inc
DUROGESIC D-TRANS
25mcg/hr Transdermal Patch
Box 5s
M: Janssen Pharmaceutics NV,
DUROGESIC D-TRANS Belgium
Box 5s I: Johnson & Johnson
FDA Reg No. DR-XY33325 (Philippines), Inc
FENDERMAL M: Hexal AG, Germany

12.5mcg/hr Transdermal Patch
Box 5s I: Sandoz Philippines Corporation
FDA Reg No. DRP-4099
FENDERMAL
Box 5s
FENDERMAL
Box 5s
FENTANYL (as citrate) M: Hameln Pharmaceuticals

50mcg/ml, ampule GmbH, Germany
2mL & 10mL
Box 10s I/D: Enlife Global Inc.
FENTANYL CITRATE M: Hospira, Inc (USA)
50mcg/ml, (100mcg/2ml) Ampule
Box 5s I/D: Pfizer, Inc
FENTANYL CITRATE M: Hameln Pharmaceuticals

50mcg/ml (100mcg/2mL & 500mcg / 10ml) GmbH, Germany
Box 5s
FDA Reg No. DR-XY32871 I/D: Pfizer, Inc
Status: on-going renewal. Filed on FEB 2022

FENTANYL (as citrate) M: Hameln Pharmaceuticals
FENTANYL 50mcg/ml, Ampule GmbH, Germany
Box of 10s, 2ml Amp
Box of 10s, 10ml Amp I/D: Enlife Global Inc

FENTYN M: Hexal AG, Germany
Sachet, Box 5s I: Sandoz Philippines Corporation
FDA Reg No. DRP-4111-01
Valid until 22 NOV 2022 D: United Laboratories, Inc
FRESANYL M: Fresenius Kabi Manufacturing

50mcg/ml (100mcg/ 2ml) SA (Pty) Ltd, South Africa
Type 1 amber glass 2 ml ampule 10s
Type 1 amber glass 10 ml ampule 5s I/D: Fresenius Kabi Philippines,
FDA Reg No. DR-XY45908 Inc
SUBLIMAX M: Yichang Humanwell

50mcg/mL, 2mL Ampule Pharmaceutical Co, Ltd, China
Box 10s
FDA Reg No. DR-XY43003 I/D: Endure Medical, Inc.
Valid until: 22 NOV 2023
SUBLIMAZE M: Glaxosmithkline Manufacturing

50mcg/ml S.P.A, Italy
2ml Ampule & 10ml Ampule
Box 5s I/D: Fresenius Kabi Philippines,
FDA Reg No. DR-XY22177 Inc
TROFENTYL M: Troikaa Pharmaceuticals Ltd,

50mcg/mL, 2ml India
Ampule, Box 5s
FDA Reg No. DR-XY35224 I/D: Troikaa Pharmaceuticals
valid until 11 DEC 2025 Philippines, Inc
BC KETACHAMP (Veterinary use) M: Bioveta A.S
KETAMINE HCL 50mg/mL Vial
Box 1s I/D: Broadchem Philippines
FDA Reg No. VR-3588 Biopharma Corporation
ETAMINE M: Swiss Parenterals Pvt, Ltd,

50mg/mL Vial India
Box 1s
FDA Reg No: DR-XY41256 I/D: Endure Medical, Inc.
KETAMAX M: Rotexmedica GmbH, Germany

50mg/mL, 10mL Vial
Box 1’s I/D: Duopharma Trade
FDA Reg No. DRP-8365 Philippines, Inc
KETAROL M: Global Pharmaceuticals,

50mg/mL, 10mL Vial Pakitan
Box 1s
FDA Reg No. DR-XY41210 I/D:Surestep Pharmaceuticals Inc,
KETOTROY 50 M: Troikaa Pharmaceuticals, Inc,

50mg/mL, 10mL Vial India
Box 1s
FDA Reg No. DR-XY47044 I/D: Troikaa Pharmaceuticals
Valid until 4 SEPT 2025 Philippines Inc,

UNIKET M: Claris Injectables Limited,
50mg/mL, 10mL Vial India
Box 5s
I: Claris Lifesciences Philippines,
Inc.
FDA Reg No. DR-6820 D: Philcare Pharma, Inc., Pasig

Valid until 13 OCT 2023
ESKETAMINE SPRAVATO M: Renaissance Lakewood LLC
(as hydrochloride) 28mg Nasal Solution (Spray) I: Johnson & Johnson Philippines,
Box of 1s Inc
CONCERTA M: Janssen Cilag Manufacturing,

METHYLPHENIDATE HCL 18mg Extended Release Tablet L.L.C, Puerto Rica
Bottle 30s
FDA Reg No. DR-XY27940 I: Johnson & Johnson Philippines
Valid until 03 AUG 2022 Inc
CONCERTA
27mg Extended Release Tablet
Bottle 30s
CONCERTA
36mg Extended Release Tablet
Bottle 30s
Valid until 03 AUG 2022
RITALIN M: Novartis Farmaceutica, SA,
10mg Tablet Spain
Blister 15’s, Box 30s
FDA Reg No. DR-XY28528 I: Novartis Healthcare
Valid until 10 APRIL 2023 Philippines., Inc.
RITALIN LA M: Recro Gainesville, LCC,

20mg Modified Release Capsule United States
HDPE bottle of 30s
FDA Reg No. DR-XY43804 I: Novartis Healthcare
Valid until 14 OCT 2024 Philippines., Inc.
RITALIN LA
30mg Modified Release Capsule
HDPE bottle of 30s
RITALIN LA
40mg Modified Release Capsule
HDPE bottle of 30s
MIDAZOLAM * DORMICUM M: Recipharm Laganes S.L.U,

15mg Tablet Spain
FDA Reg No: DR-XY41657 I/D: Zuellig Pharma Corporation,
Valid until 5 FEB 2023 Paranaque
DORMICUM M: Cenexi, France

5mg/mL, 1mL Ampule
Box 10s I/D: Zuellig Pharma Corporation,
FDA Reg No: DR-XY28584 Paranaque

DORMICUM
1mg/mL, 5mL (5mg/ 5ml) Ampule
Box 10s
FDA Reg No: DR-XY28582
DORMICUM
5mg/mL, 3mL (15mg/3ml) Ampule
Box 5s
Valid until 28 APRIL 2023
DORMID M: PT Novell Pharmaceutical

1mg/ml (5mg/5ml) Laboratories, Indonesia
Ampule, Box 10s
FDA Reg No. DR-XY44212 I/D: Endure Medical, Inc.
DORMID
5mg/ml (15mg/3ml)
Ampule, Box 5s
DORMIZOL M: Harson Laboratories, India
5mg/ml
1mL & 3ml Ampule I/D: Phil Pharmawealth, Inc.
Box 10s
HYPOZAM M: Brookes Pharma (Private)
1mg/ml, Limited, Pakistan
3mL & 5ml, Ampule
Box 10s I/D: Sahar International Trading
FDA Reg No.: DR-XY38463 Inc.
MIDAZOLEX M: Myungmoon Pharmaceutical
1mg/mL, (5mg /5mL) Ampule Co, Ltd, South Korea
Box 10s
FDA Reg No: DRP-4892 I/D: Delex Pharma International,
Valid until 05 APR 2023 Inc
MIDAZOLEX
5mg/mL, (15mg/3mL) Ampule
Box 5s
MIZAM M: Global Pharmaceuticals,

1mg/mL, 5mL Ampule Pakistan
Box 10s
FDA Reg No : DR-XY40893 I/D: Surestep Pharmaceuticals
Valid until 02 AUG 2022 Inc.
SEDACUM M: PT Ferron Par

5mg/mL, 3ml Ampule Pharmaceuticals, Indonesia
Box 5s
FDA Reg No : DRP-8768 I: Glorious Dexa Mandaya, Inc
SEZOLAM M: Claris Injectables Limited-

5mg/ml, 3ml Ampule Clarion 1, India
Box of 5s,10s, 25s
Inc.
FDA Reg No : DRP-6984
Valid until : 5 DEC 2023 D: Macropharma Corporation

MIDAZOLAM HCL HYPMID (as hydrochloride) M: Mefar Ilac Sanayii A.S, Turkey
5mg/ml, (15mg / 3ml ) Ampule
Box of 5s I/D: Ambica International
Corporation
FDA Reg No : DRP-10702
Valid until : 10 NOV 2026
MIDAZOLAM (as hydrochloride) M: Swiss Parenterals Pvt. Ltd,
1mg/ml, Vial India
5ml & 10ml Vial
FDA Reg No : DR-XY41312 I/D: Endure Medical Inc.
MIDAMICUM (as hydrochloride) M: Mefar Ilac Sanayii A.S., Turkey

5mg/ml, (15mg / 3ml) Ampule
Box of 5s I/D: Ambica International
FDA Reg No : DRP-10703 Corporation
SEDOZ M: Baxter Pharmaceuticals India

1mg/ml, 5ml Vial Private Limited, India
Box of 15’s
FDA Reg No : DR-XY30768 Inc.
Valid until : 23 MAY 2025
D: Macropharma Corporation
ZYLAM M: Laboratorios Normon, S.A
1mg /mL (5mg/5mL) Madrid, Spain
5mL vial
I/D : The Cathay Drug Co. Inc
FDA Reg No : DR-XY47356
Valid until : 12 AUG 2026
MORPHINE HCL MORPHINA M: HBM Pharma S.R.O, Slovak
10mg/ml, Ampule Republic
Box of 10s
FDA Reg No: DRP-10596 I/D : Ambica International
Valid until 21 OCT 2026 Corporation
MORPHINE SULFATE MORPHINE SULFATE M/D: Hizon Laboratories, Inc,

10mg Tablet Antipolo, Rizal
Strip Foil 4s, Box 100s
Valid until 17 JUN 2026
MORPHINE SULFATE
10mg Tablet

MORPHINE SULFATE
30mg Tablet
MORPHINE SULFATE
10mg/ml, Ampule
Box 100s
FDA Reg No: DR-9208
MORPHINE SULFATE
16mg/ml, Ampule
Box 100s
FDA Reg No: DR-9210

MORPHINE SULFATE M: Hameln Pharmaceutical
10mg/mL, Ampule GmbH, Germany
Box 5s
FDA Reg No: DR-XY33322 I/D: Pfizer, Inc.
MST CONTINUS M: Bard Pharmaceuticals Ltd,

10mg Modified Release Tablet United Kingdom
FDA Reg No: DR-XY13020 I: Mundipharma Distribution
Valid until 17 JULY 2026 GmbH (Philippine Branch)
MST CONTINUS
30mg Modified Release Tablet
MST CONTINUS
60mg Modified Release Tablet
Valid until 16 JUL 2023
ANALIN M: Medicaids Pakistan (Pvt) Ltd,

NALBUPHINE 10mg/mL, 1ml Ampule Pakistan
Box 10s
FDA Reg. No. DR-XY35860 I/D: Sahar International Trading,
Valid until 21 MAY 2024 Inc
ANALIN
20mg/mL, 1mL, ampule
Box 10s
FDA Reg. No. DRXY-40127
ENDURPIN M: Myungmoon Pharmaceuticals

10mg/mL, 1mL Ampule Co., Ltd, South Korea
Box 10s
FDA Reg No: DRP-8319 I/D: Delex Pharma International,
Valid until 15 AUG 2024 Inc
NALBULIN M: Global Pharmaceuticals,

10mg/ml, 1ml, Ampule Pakistan
Blister pack, 5s
FDA Reg No: DR-XY41208 I/D: Surestep Pharmaceuticals,
Valid until 4 SEPT 2022 Inc.
NALBUPHINE HYDROCHLORIDE M: Norris Medicines, Ltd, India

10mg/ml, 1ml
Box 10s I/D: I.E Medica, Inc.
NALBUPHINE HYDROCHLORIDE
20mg/ml, 1ml
Box 10s

NALBUPHINE HYDROCHLORIDE M: Hospira, Inc, USA
(Preservative and Anti-Oxidant Free)
10mg/mL, 1ml, Ampule I/D: Pfizer Inc.
Blister 10s

NUBAIN M: Hizon Laboratories Inc.,
10mg/mL, 1ml, Ampule
Box 10s and 100s T: A. Menarini Philippines, Inc.
FDA Reg. No. DR-X3037
NUKAINE M: Hana Pharmaceuticals Co.,

10mg/ml, 1ml Ltd, South Korea
Box 10s
FDA Reg No. DR-XY40522 I/D: Endure Medical Inc,
SEDAFIN M: The ACME Laboratories
10mg/ml, 1ml Limited, Bangladesh
Box 5s
FDA Reg No: DR-XY45030 I/D: Euro Generics International
Valid until: 4 FEB 2026 Philippines, Inc
OXYCONTIN M: Bard Pharmaceuticals Ltd,

OXYCODONE HCL 10mg Prolonged Release Tablet United Kingdom
FDA Reg No: DR-XY27751 I/D: Mundipharma Distribution
Valid until 19 FEB 2021 GmbH (Philippine Branch)
DISCONTINUED BY THE IMPORTER
OXYCONTIN
20mg Prolonged Release Tablet
OXYCONTIN
OXYCONTIN
OXYCONTIN NEO M: Purdue Pharmaceuticals, L.P,
10mg Controlled Release Tablet United States of America
Blister 10s, Box 20s, 30s, & 40s
valid until 15 DEC 2026 GmbH (Philippine Branch)
OXYCONTIN NEO
20mg Controlled Release Tablet
valid until 15 DEC 2026
OXYCONTIN NEO
OXYCONTIN NEO

OXYCODONE HCL OXYCONTIN NEO M: Purdue Pharmaceuticals, L.P,
80mg Controlled Release Tablet United States of America
Valid until 15 DEC 2026 GmbH (Philippine Branch)
OXYNORM M: Bard Pharmaceuticals Ltd,

5mg Capsule United Kingdom
Blister Pack x 14s (Box of 28’s)
Valid until 20 JULY 2024 GmbH (Philippine Branch)
OXYNORM
10mg Capsule
Blister Pack x 14s (Box of 28’s)
OXYNORM LIQUID
5mg/5ml Oral Solution M: Mundipharma
Amber glass bottle, 250ml (1’s) Pharmaceuticals Ltd, Cyprus
Valid until: 21 DEC 2024 I: Mundipharma Distribution
GmbH (Philippine Branch)
OXYNORM
10mg/ml (20 mg / 2ml)
Colorless glass ampule, 1ml and 2ml
(Box of 5’s)
Valid until: 11 MAY 2023
TARGIN M: Bard Pharmaceuticals Limited,
OXYCODONE HCL + 5mg/2.5mg Prolonged-Released Tablet United Kingdom
NALOXONE HCL Blister 14s, Box 28s
Valid until 18 SEPT 2026 GmbH (Philippine Branch)
TARGIN
10mg/5mg Prolonged-Released Tablet
Status: on-going renewal. Filed on FEB 26 2020
TARGIN
TARGIN
Status: on-going renewal. Filed on FEB 26 2020
PENTOBARBITAL SODIUM DOLETHAL M : Vetoquinol SA, France
200mg/ml, 100ml Vial
Vial I : Agfield International
FDA Reg No: VR-3537 Corporation
PETHIDINE 50mg/mL, 1mL, ampule M: Siegfried Hameln GmbH,

HYDROCHLORIDE Box 10s Germany
Valid until 14 MAR 2027 I/D: Enlife Global, Inc

PETHIDINE / MEPERIDINE DEMEROL M: Hospira, Inc, United States of
50mg/mL, 2mL, ampule America
Box 25s
FDA Reg No: DR-2148 I: Pfizer, Inc.
DEMEROL
50mg/mL, 30mL, vial
Box 1s
FDA Reg No: DR-2149
DEMETOR M: Yichang Humanwell

50mg/mL, (100 mg/ 2ml) Ampule Pharmaceutical Co,. Ltd, China
Box 10s
FDA Reg No: DR-XY46256 I/D: Endure Medical, Inc
PHENOBARBITAL SODIUM LUMINAL I: Pfizer, Inc

130mg/mL, 1mL, ampule
Box 5s D: Zuellig Pharma Corporation
FDA Reg No: DR-X7787
DISCONTINUED BY THE MANUFACTURER
* PHENOBARBITAL M: Amherst Laboratories, Inc,
15mg, Tablet Laguna
Bottle 100s
FDA Reg No: DR-X1824 D: Philusa Corporation
* PHENOBARBITAL
30mg, Tablet
Bottle 100s
FDA Reg No: DR-5064
* PHENOBARBITAL
60mg, Tablet
Bottle 100s
FDA Reg No: DR-X2017
* PHENOBARBITAL
90mg, Tablet
Bottle 100s
PHENTERMINE * DUROMINE M: Douglas Manufacturing Ltd,

15mg capsule New Zealand
FDA Reg No: DR-XY26998 I/D: Metro Drug, Inc
* DUROMINE
30mg, capsule
REMIFENTANIL HCl SUBLIFEN M: Yichang Humanwell

1mg Vial Pharmaceutical Co., Ltd, China
Box 5s
FDA Reg No: DR-XY45774 I/D: Endure Medical Inc
SUBLIFEN
2mg Vial
Box 5s

ZOLPIDEM * DACTIVE M: Cadila Healthcare Limited,
10mg Tablet India
Blister 100s
FDA Reg No: DRP-7184 I/D: Zydus Healthcare Philippines,
Valid Until 19 JAN 2026 Inc
* SITINOX M: Lunan Better Pharmaceutical
10mg, Film-Coated Tablet Co Ltd, China
FDA Reg. No.: DR-39241 I/D: Sahar International Trading,
Valid Until 30 MAR 2026 Inc
* STILNOX M : Sanofi Winthrop Industrie,

10mg, Film-Coated Tablet France
FDA Reg. No.: DRP-014 I: Sanofi-Aventis Philippines, Inc
Valid until 13 APRIL 2024
* ZOLDEM M: Amherst Laboratories, Inc,

10mg, film coated tablet Laguna
FDA Reg. No.: DR-XY32230 T: UNILAB, Inc
* ZOPLINOVA M: Innova Captab India

10mg, film coated tablet
Blister 10s, Box 30s I/D: I.E. Medica, Inc
FYBT
04/01/2022

LIST OF DRUG PREPARATIONS CONTAINING PHILIPPINE TABLE 1 CONTROLLED CHEMICALS
DISPENSING / PRESCRIBING / RECORDING / REPORTING:

Subject to Food and Drugs Administration (FDA) rules and regulations.
LICENSE REQUIRED:
Manufacturer / Repacker S5-C License
Importer S5-I License
Exporter S5-E License
Drug Preparation Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)
***ERGOMETRINE / Various Pharmaceutical Drug Preparations Various Entities

ERGONOVINE
***ERGOTAMINE Various Pharmaceutical Drug Various Entities

Preparations
***NOREPHEDRINE / Various Pharmaceutical Drug Preparations Various Entities

PHENYLPROPANOLAMINE
Note
*** Only importer, exporter and manufacturer will require registration of license. For importation of a finished product that
exceeds the equivalent quantities of 0.010grams ergometrine / ergonovine, 0.020grams ergotamine and / or 2.5Kg
norephedrine per importation, an import permit shall be required. Each import or export transaction shall be reported to
PDEA not later than five (5) working days before date of importation or exportation of the shipment.
Section 4 (5) Board Regulation 1 Series 2014.
LEGEND:
* All oral forms of Philippine Schedule 4 and 5 Dangerous Drugs are:
1. Exempted from DOH Special Prescription for Dangerous Drugs (SPFFD) per Section 4 (4a) Board
Regulation No. 1 Series 2014. To be prescribed in an ordinary prescription form in triplicate copies containing
the standard information of a prescription Section 31 (3) Board Regulation No. 1 Series 2014.
2. Exempted (Local Order Permit) for transactions between wholesaler and retail drugstore or hospital
pharmacy.
** Exempted from DOH Special Prescription for Dangerous Drugs (SPFFD). To be prescribed in ordinary prescription form in
triplicate copies, bearing the current S2 License of the prescribing medical practitioner.
Section 4 (2b) Board Regulation 1 Series 2014.
ITEMS IN RED FONT – FOR REVALIDATION / AWAITING SUBMISSION OF UPDATED CPR

ITEMS IN BLUE FONT – DELISTED / DISCONTINUED DRUG PREPARATION
Noted by:
DERRICK ARNOLD C CARREON, CESE

DIRECTOR, COMPLIANCE SERVICE

DDP LIST AS OF APRIL Edited APRIL 1 04apr2022

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DDP LIST AS OF APRIL Edited APRIL 1 04apr2022

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GUIDE TO MEDICAL / PARAMEDICAL PRACTITIONERS

LIST OF DANGEROUS DRUG PREPARATIONS (DDPs)

ACQUISITION / DISPENSING / PRESCRIBING:

Dangerous Drug Brand Name, Importer (I) / Distributor (D) /

* AXAL M: Amson Vaccines and Pharma

* XANOR M: Sanico NV, Belgium

Page 1 / 15/fybt/April 1, 2022

* ZOLDAC 0.25 M: Cadila Healthcare Limited,

* ZOLGEN M: Lloyd Laboratories Inc.,

* LEXOTAN M: Delpharm Milano SRL, Italy

** NORSPAN M: LTS Lohmann Therapie-

Page 2 / 15/fybt/April 1, 2022

* CLONOTRIL-0.5 M : Torrent Pharmaceuticals Ltd.,

* EPILINE 2 M: Cadila Healthcare Limited,

* RIVOTRIL M: Recipharm Leganes S.L.U,

* TRANXENE M: Sanofi-Aventis, S.A , Spain

ANXIOL M: Tai Yu Chemical &

ANXOL M: Ciron Drugs &

LORCAM M: T.P Drug Laboratories (1969)

* PAMIZEP M: Shine Pharmaceuticals

Page 3 / 15/fybt/April 1, 2022

VALIUM M: Recipharm Leganes, S.L.U,

VALZEPAM M: L.B.S Laboratory Ltd, Part.,

* VEXEPAM M: Mercury Laboratories Ltd,

EPHEDRINE SULFATE M: Hizon Laboratories, Inc.,

FEDRIN M: Geofman Pharmaceuticals,

ABSTRAL M: Aesica Queensborough Ltd,

Page 4 / 15/fybt/April 1, 2022

FENDERMAL M: Hexal AG, Germany

FENTANYL (as citrate) M: Hameln Pharmaceuticals

FENTANYL CITRATE M: Hameln Pharmaceuticals

Page 5 / 15/fybt/April 1, 2022

FDA Reg No. DRP-8885

FRESANYL M: Fresenius Kabi Manufacturing

SUBLIMAX M: Yichang Humanwell

SUBLIMAZE M: Glaxosmithkline Manufacturing

TROFENTYL M: Troikaa Pharmaceuticals Ltd,

ETAMINE M: Swiss Parenterals Pvt, Ltd,

KETAMAX M: Rotexmedica GmbH, Germany

KETAROL M: Global Pharmaceuticals,

KETOTROY 50 M: Troikaa Pharmaceuticals, Inc,

Page 6 / 15/fybt/April 1, 2022

FDA Reg No. DR-6820 D: Philcare Pharma, Inc., Pasig

CONCERTA M: Janssen Cilag Manufacturing,

RITALIN LA M: Recro Gainesville, LCC,

MIDAZOLAM * DORMICUM M: Recipharm Laganes S.L.U,

DORMICUM M: Cenexi, France

Page 7 / 15/fybt/April 1, 2022

DORMID M: PT Novell Pharmaceutical

MIZAM M: Global Pharmaceuticals,

SEDACUM M: PT Ferron Par

SEZOLAM M: Claris Injectables Limited-

Page 8 / 15/fybt/April 1, 2022

MIDAMICUM (as hydrochloride) M: Mefar Ilac Sanayii A.S., Turkey

SEDOZ M: Baxter Pharmaceuticals India

MORPHINE SULFATE MORPHINE SULFATE M/D: Hizon Laboratories, Inc,

FDA Reg No: DR-XY27441

Page 9 / 15/fybt/April 1, 2022

MST CONTINUS M: Bard Pharmaceuticals Ltd,

ANALIN M: Medicaids Pakistan (Pvt) Ltd,

ENDURPIN M: Myungmoon Pharmaceuticals

NALBULIN M: Global Pharmaceuticals,

NALBUPHINE HYDROCHLORIDE M: Norris Medicines, Ltd, India