Active ingredient
Promethazine
129 finished FDA listings contain Promethazine as their only active ingredient; 26 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PROMETHAZINE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Solution, Suppository, Syrup, Tablet
- Routes
- Intramuscular, Intravenous, Oral, Rectal
- Manufacturers / labelers
- 47
- Strengths listed
- 12.5 mg/1 · 25 mg/1 · 25 mg/ml · 50 mg/1 · 50 mg/ml · 6.25 mg/5ml
- Brand names in FDA listings
- Phenergan, Promethegan
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8745
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 083312 | HIKMA | 1973-09-19 | 23 |
| ANDA 083426 | WATSON LABS | 1973-09-19 | 4 |
| ANDA 083711 | WATSON LABS | 1973-09-21 | 1 |
| ANDA 087953 | PHARMOBEDIENT | 1982-11-15 | 2 |
| ANDA 087165 | COSETTE PHARMS NC | 1987-08-14 | 1 |
| ANDA 040026 | CHARTWELL RX | 1998-09-25 | 2 |
| ANDA 040428 | COSETTE PHARMS NC | 2002-02-05 | 3 |
| ANDA 040500 | PADAGIS ISRAEL | 2003-06-30 | 6 |
| ANDA 040596 | ZYDUS PHARMS USA | 2005-11-18 | 43 |
| ANDA 040643 | PHARM ASSOC | 2006-04-26 | 1 |
| ANDA 040712 | KVK TECH | 2006-07-31 | 18 |
| ANDA 040737 | XGEN PHARMS | 2008-04-24 | 3 |
| ANDA 040891 | STRIDES PHARMA | 2009-03-13 | 2 |
| ANDA 091179 | AMNEAL PHARMS NY | 2010-12-13 | 13 |
| ANDA 091675 | COSETTE PHARMS NC | 2012-06-28 | 3 |
| ANDA 213890 | QUAGEN | 2021-07-12 | 2 |
| ANDA 216446 | ANNORA PHARMA | 2022-11-02 | 2 |
Official labeling on DailyMed
- PROMETHAZINE HYDROCHLORIDE TABLET [DIRECT RX] · version 8 · 2026-09-10
- PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 1 · 2026-09-07
- PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG] · version 1 · 2026-09-03
- PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 7 · 2026-08-25
- PROMETHAZINE HYDROCHLORIDE TABLET [UNIT DOSE SOLUTIONS, INC.] · version 2 · 2026-08-20
- PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 4 · 2026-08-03
- PROMETHAZINE HYDROCHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-07-07
- PROMETHAZINE HYDROCHLORIDE TABLET [SPORTPHARM LLC] · version 3 · 2026-07-06
- PROMETHAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 22 · 2026-07-06
- PROMETHAZINE HYDROCHLORIDE TABLET [ASCLEMED USA INC.] · version 2 · 2026-07-06
- PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 5 · 2026-07-02
- PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 104 · 2026-06-08
Showing the 12 most recent of 99 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.