Active ingredient
Vitamin B12
56 finished FDA listings contain Vitamin B12 as their only active ingredient; 110 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- COBALAMIN, CYANOCOBALAMIN
- Dosage forms
- Injection, Injection, Solution, Spray, Spray, Metered
- Routes
- Intramuscular, Nasal, Subcutaneous
- Manufacturers / labelers
- 25
- Strengths listed
- 1000 ug/ml · 2 mg/ml · 500 ug/1
- Brand names in FDA listings
- Nascobal, Non-Proprietary Name
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 11248
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 080515 | WEST-WARD PHARMS INT | 1971-10-20 | 4 |
| ANDA 080737 | AM REGENT | 1972-04-26 | 6 |
| ANDA 080557 | FRESENIUS KABI USA | 1973-06-20 | 3 |
| NDA 021642 | ENDO OPERATIONS | 2005-01-31 | 1 |
| ANDA 206503 | SOMERSET THERAPS LLC | 2015-12-11 | 4 |
| ANDA 209429 | SOMERSET THERAPS LLC | 2018-12-18 | 3 |
| ANDA 209255 | H2-PHARMA | 2018-12-18 | 5 |
| ANDA 212458 | PADAGIS ISRAEL | 2020-09-09 | 1 |
| ANDA 214390 | GLAND | 2020-09-24 | 8 |
| ANDA 213874 | EUGIA PHARMA | 2020-12-08 | 1 |
| ANDA 214655 | ZYDUS PHARMS | 2022-04-15 | 6 |
| ANDA 215417 | SOLA PHARMS | 2022-04-15 | 2 |
| ANDA 215107 | SAGENT PHARMS INC | 2022-11-15 | 1 |
| ANDA 210629 | LUPIN | 2023-06-30 | 1 |
| ANDA 217839 | MANKIND PHARMA | 2024-07-10 | 5 |
| ANDA 214316 | MEITHEAL | 2024-11-15 | 4 |
Official labeling on DailyMed
- CYANOCOBALAMIN INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-09-04
- CYANOCOBALAMIN INJECTION, SOLUTION [LIFESTAR PHARMA LLC] · version 7 · 2026-08-10
- CYANOCOBALAMIN INJECTION, SOLUTION [NORTHSTAR RXLLC] · version 3 · 2026-08-10
- NON-PROPRIETARY NAME (CYANOCOBALAMIN) INJECTION [XSEER PHARMACEUTICALS] · version 2 · 2026-06-02
- NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR HEALTH USA, LLC] · version 15 · 2026-05-28
- CYANOCOBALAMIN INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 10 · 2026-05-11
- CYANOCOBALAMIN INJECTION CYANOCOBALAMIN INJECTION [PLANO PHARMACEUTICALS INC.] · version 2 · 2026-03-26
- CYANOCOBALAMIN INJECTION [SPORTPHARM LLC] · version 2 · 2026-02-06
- CYANOCOBALAMIN INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 6 · 2026-01-07
- CYANOCOBALAMIN INJECTION [SOLA PHARMACEUTICALS] · version 9 · 2025-12-09
- CYANOCOBALAMIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES] · version 3 · 2025-12-08
- CYANOCOBALAMIN INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 2 · 2025-11-17
Showing the 12 most recent of 37 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.