Active ingredient
Hydroxocobalamin
3 finished FDA listings contain Hydroxocobalamin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- HYDROXOCOBALAMIN, HYDROXOCOBALAMIN ACETATE, HYDROXOCOBALAMIN HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intramuscular, Intravenous, Subcutaneous
- Manufacturers / labelers
- 3
- Strengths listed
- 1 mg/ml · 1000 ug/ml · 5 g/250ml
- Brand names in FDA listings
- Cyanokit
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5514
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 085998 | ACTAVIS | 1978-08-16 | 1 |
| NDA 022041 | BTG INTL | 2006-12-15 | 1 |
Official labeling on DailyMed
- HYDROXOCOBALAMIN INJECTION [XSEER PHARMACEUTICALS] · version 2 · 2026-06-02
- HYDROXOCOBALAMIN INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] · version 5 · 2024-02-07
- CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] · version 2 · 2023-05-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.