Cyanokit
These highlights do not include all the information needed to use CYANOKIT safely and effectively. See full prescribing information for CYANOKIT. CYANOKIT (hydroxocobalamin for injection) for intravenous infusion Initial U.S. Approval: 1975
Approved
Approval ID
d56fcc8d-bd64-46ab-b0c0-2124bd745a6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
BTG INTERNATIONAL INC.
DUNS: 617382395
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50633-310
Application NumberNDA022041
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydroxocobalamin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2021
FDA Product Classification
INGREDIENTS (2)
HydroxocobalaminActive
Quantity: 5 g in 250 mL
Code: Q40X8H422O
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT