Active ingredient
Thiamine
21 finished FDA listings contain Thiamine as their only active ingredient; 144 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- COCARBOXYLASE, THIAMINE, THIAMINE HCL, THIAMINE HYDROCHLORIDE, THIAMINE MONONITRATE
- Dosage forms
- Injection, Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 17
- Strengths listed
- 100 mg/ml · 200 mg/2ml
- Brand names in FDA listings
- Thiamine
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10454
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 080556 | FRESENIUS KABI USA | 1972-06-20 | 4 |
| ANDA 080571 | DR REDDYS | 1974-02-26 | 3 |
| ANDA 080575 | WEST-WARD PHARMS INT | 1975-06-24 | 2 |
| ANDA 091623 | MYLAN INSTITUTIONAL | 2012-06-25 | 2 |
| ANDA 206106 | SAGENT PHARMS INC | 2017-12-01 | 1 |
| ANDA 208703 | EUGIA PHARMA | 2022-04-20 | 1 |
| ANDA 215692 | CAPLIN | 2023-03-06 | 3 |
| ANDA 217181 | ONESOURCE SPECIALTY | 2024-10-29 | 3 |
| ANDA 218471 | ASPIRO | 2024-11-06 | 1 |
| ANDA 217800 | GLAND | 2025-02-24 | 1 |
Official labeling on DailyMed
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-02
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 2 · 2026-08-04
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [FOSUN PHARMA USA INC.] · version 3 · 2026-07-31
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 6 · 2026-07-29
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] · version 3 · 2026-05-25
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 4 · 2026-05-11
- THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2026-02-13
- THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2026-02-13
- THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2026-02-13
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] · version 4 · 2025-11-17
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 2 · 2025-11-17
- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 6 · 2025-09-29
Showing the 12 most recent of 21 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.