Active ingredient
Chlorpromazine
126 finished FDA listings contain Chlorpromazine as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CHLORPROMAZINE, CHLORPROMAZINE HYDROCHLORIDE
- Dosage forms
- Concentrate, Injection, Tablet, Tablet, Coated, Tablet, Film Coated, Tablet, Sugar Coated
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 33
- Strengths listed
- 10 mg/1 · 100 mg/1 · 100 mg/ml · 200 mg/1 · 25 mg/1 · 25 mg/ml · 30 mg/ml · 50 mg/1
- Brand names in FDA listings
- Chlorpromazine Hydrochloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2403
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 080365 | DR REDDYS | 1974-02-13 | 2 |
| ANDA 083386 | UPSHER SMITH LABS | 1974-07-09 | 1 |
| ANDA 084115 | UPSHER SMITH LABS | 1974-07-09 | 2 |
| ANDA 084112 | UPSHER SMITH LABS | 1974-07-09 | 2 |
| ANDA 084114 | UPSHER SMITH LABS | 1974-07-09 | 2 |
| ANDA 084113 | UPSHER SMITH LABS | 1974-07-09 | 2 |
| ANDA 083329 | HIKMA | 1974-07-25 | 4 |
| ANDA 080983 | SCIEGEN PHARMS | 1976-03-01 | 2 |
| ANDA 209755 | AMNEAL PHARMS CO | 2018-09-10 | 15 |
| ANDA 213368 | ZYDUS LIFESCIENCES | 2020-01-17 | 12 |
| ANDA 211816 | EUGIA PHARMA | 2020-07-07 | 2 |
| ANDA 214256 | SUN PHARM | 2020-10-26 | 5 |
| ANDA 212996 | LANNETT CO INC | 2021-01-22 | 10 |
| ANDA 212144 | GLENMARK PHARMS LTD | 2021-03-23 | 5 |
| ANDA 214542 | GENUS | 2021-06-02 | 2 |
| ANDA 212630 | CHARTWELL RX | 2021-11-29 | 10 |
| ANDA 214827 | MSN | 2022-01-27 | 14 |
| ANDA 217350 | ALEMBIC | 2023-07-18 | 11 |
| ANDA 217275 | ZYDUS PHARMS | 2024-03-13 | 4 |
| ANDA 218229 | REGCON HOLDINGS | 2024-09-24 | 2 |
| ANDA 216911 | GLAND | 2024-10-04 | 4 |
| ANDA 218272 | ASPIRO | 2024-11-18 | 2 |
| ANDA 216724 | THINQ PHARM-CRO PVT | 2024-12-10 | 2 |
| ANDA 216788 | AUROBINDO PHARMA LTD | 2025-04-25 | 5 |
| ANDA 216678 | RUBICON RESEARCH | 2025-10-10 | 2 |
| ANDA 216092 | MSN | 2026-01-26 | 2 |
Official labeling on DailyMed
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-07
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-09-07
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-02
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] · version 7 · 2026-08-27
- CHLORPROMAZINE TABLET [REMEDYREPACK INC.] · version 1 · 2026-08-20
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 11 · 2026-08-17
- CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC.] · version 8 · 2026-08-12
- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 9 · 2026-06-30
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) TABLET, SUGAR COATED [SUN PHARMACEUTICAL INDUSTRIES INC] · version 7 · 2026-06-08
- CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [AMERICAN HEALTH PACKAGING] · version 3 · 2026-06-03
- CHLORPROMAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] · version 3 · 2026-05-26
- CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC.] · version 4 · 2026-05-04
Showing the 12 most recent of 44 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.