Active ingredient
Diazepam
129 finished FDA listings contain Diazepam as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DIAZEPAM
- Dosage forms
- Gel, Injection, Injection, Solution, Solution, Solution, Concentrate, Spray, Tablet
- Routes
- Intramuscular, Intravenous, Nasal, Oral, Rectal
- Manufacturers / labelers
- 51
- Strengths listed
- 10 mg/.1ml · 10 mg/1 · 10 mg/2g · 10 mg/2ml · 2 mg/1 · 2.5 mg/.5ml · 20 mg/4g · 20 mg/4ml · 5 mg/.1ml · 5 mg/1 · 5 mg/5ml · 5 mg/ml · 7.5 mg/.1ml
- Brand names in FDA listings
- Diazepam, Valium, Valtoco
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3322
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 |
|---|---|---|---|
| NDA 013263 | WAYLIS THERAP | 1963-11-15 | 5 |
| ANDA 070325 | MYLAN | 1985-09-04 | 24 |
| ANDA 070311 | HIKMA | 1985-12-16 | 3 |
| ANDA 070313 | HIKMA | 1985-12-16 | 3 |
| ANDA 070302 | CHARTWELL RX | 1985-12-20 | 1 |
| ANDA 070303 | CHARTWELL RX | 1985-12-20 | 1 |
| ANDA 070304 | CHARTWELL RX | 1985-12-20 | 1 |
| ANDA 070464 | NUVO PHARM | 1986-02-25 | 3 |
| ANDA 071321 | IVAX SUB TEVA PHARMS | 1986-12-10 | 15 |
| ANDA 071307 | IVAX SUB TEVA PHARMS | 1986-12-10 | 7 |
| ANDA 071322 | IVAX SUB TEVA PHARMS | 1986-12-10 | 13 |
| ANDA 071415 | HIKMA | 1987-04-03 | 1 |
| ANDA 070928 | HIKMA | 1987-04-03 | 4 |
| ANDA 071583 | HOSPIRA | 1987-10-13 | 3 |
| ANDA 072079 | HOSPIRA | 1988-12-20 | 1 |
| NDA 020124 | US ARMY | 1990-12-05 | 1 |
| NDA 020648 | BAUSCH | 1997-07-29 | 3 |
| ANDA 204433 | CHARTWELL MOLECULAR | 2014-04-14 | 1 |
| ANDA 206477 | CHARTWELL MOLECULAR | 2016-06-24 | 2 |
| ANDA 210363 | REGCON HOLDINGS | 2019-03-18 | 4 |
| ANDA 211998 | REGCON HOLDINGS | 2019-12-26 | 2 |
| NDA 211635 | NEURELIS INC | 2020-01-10 | 4 |
| ANDA 214745 | FRESENIUS KABI USA | 2022-11-10 | 1 |
| ANDA 091076 | NOVEL LABS INC | 2023-05-30 | 2 |
| ANDA 217843 | AUROBINDO PHARMA LTD | 2023-12-14 | 10 |
| ANDA 218450 | ALEMBIC | 2024-04-25 | 4 |
| ANDA 218422 | DR REDDYS | 2024-07-18 | 2 |
| ANDA 217468 | NAVINTA LLC | 2025-11-14 | 6 |
| ANDA 219882 | BAXTER HLTHCARE CORP | 2026-07-28 | 2 |
Official labeling on DailyMed
- DIAZEPAM INJECTION [CIVICA, INC.] · version 2 · 2026-09-10
- DIAZEPAM TABLET [CARDINAL HEALTH 107, LLC] · version 19 · 2026-09-07
- VALIUM (DIAZEPAM) TABLET [WAYLIS THERAPUETICS LLC] · version 11 · 2026-08-14
- DIAZEPAM INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 1 · 2026-08-07
- DIAZEPAM INJECTION, SOLUTION [REMEDYREPACK INC.] · version 18 · 2026-07-24
- DIAZEPAM INJECTION, SOLUTION [REMEDYREPACK INC.] · version 1 · 2026-07-23
- DIAZEPAM TABLET [REMEDYREPACK INC.] · version 19 · 2026-07-13
- DIAZEPAM INJECTION DIAZEPAM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2026-07-10
- DIAZEPAM INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC] · version 5 · 2026-06-26
- DIAZEPAM TABLET [REMEDYREPACK INC.] · version 25 · 2026-06-24
- DIAZEPAM TABLET [UNIT DOSE SOLUTIONS, INC.] · version 1 · 2026-06-22
- VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC] · version 15 · 2026-06-05
Showing the 12 most recent of 90 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.