Active ingredient
Hydralazine
149 finished FDA listings contain Hydralazine as their only active ingredient; 6 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- HYDRALAZINE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Tablet, Tablet, Film Coated
- Routes
- Intramuscular, Intravenous, Oral
- Manufacturers / labelers
- 43
- Strengths listed
- 10 mg/1 · 100 mg/1 · 20 mg/ml · 25 mg/1 · 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5470
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 086242 | HERITAGE | 1978-10-23 | 7 |
| ANDA 088468 | PLIVA | 1984-05-01 | 6 |
| ANDA 088467 | PLIVA | 1984-05-01 | 7 |
| ANDA 089098 | PLIVA | 1985-12-18 | 2 |
| ANDA 089097 | PLIVA | 1985-12-18 | 3 |
| ANDA 040136 | AM REGENT | 1997-06-30 | 3 |
| ANDA 040388 | FRESENIUS KABI USA | 2001-03-13 | 12 |
| ANDA 040901 | HETERO LABS LTD III | 2008-09-12 | 19 |
| ANDA 090255 | INVAGEN PHARMS | 2008-12-15 | 5 |
| ANDA 040730 | RISING | 2009-04-21 | 1 |
| ANDA 090527 | GLENMARK PHARMS LTD | 2009-05-29 | 4 |
| ANDA 040858 | HERITAGE PHARMS INC | 2010-02-26 | 22 |
| ANDA 200737 | ALKEM LABS LTD | 2012-12-07 | 4 |
| ANDA 202938 | NAVINTA LLC | 2013-03-28 | 2 |
| ANDA 200770 | STRIDES PHARMA | 2013-05-03 | 6 |
| ANDA 203845 | CADILA PHARMS LTD | 2014-09-18 | 7 |
| ANDA 205236 | SCIEGEN PHARMS | 2017-05-26 | 29 |
| ANDA 213667 | HIKMA | 2020-12-18 | 2 |
| ANDA 215147 | EUGIA PHARMA | 2023-02-13 | 2 |
| ANDA 211010 | MACLEODS PHARMS | 2024-08-21 | 4 |
| ANDA 217501 | KINDOS | 2025-06-02 | 1 |
| ANDA 219797 | BAXTER HLTHCARE CORP | 2025-07-17 | 1 |
Official labeling on DailyMed
- HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 8 · 2026-08-31
- HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] · version 19 · 2026-08-17
- HYDRALAZINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.] · version 4 · 2026-08-17
- HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] · version 8 · 2026-08-17
- HYDRALAZINE HYDROCHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-08-10
- HYDRALAZINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] · version 3 · 2026-07-28
- HYDRALAZINE HYDROCHLORIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 3 · 2026-07-15
- HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC] · version 3 · 2026-07-01
- HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 4 · 2026-06-15
- HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 6 · 2026-06-15
- HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC] · version 10 · 2026-06-15
Showing the 12 most recent of 95 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.