Hydroxocobalamin
HYDROXOCOBALAMIN INJECTION USP Rx Only
Approved
Approval ID
17e7d7d8-d27c-4888-84b9-45305df62066
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3548
Application NumberANDA085998
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 1, 2017
FDA Product Classification
INGREDIENTS (7)
ACETIC ACIDInactive
Quantity: 0.442 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROXOCOBALAMIN ACETATEActive
Quantity: 1000 ug in 1 mL
Code: S535M27N3Q
Classification: ACTIM
SODIUM ACETATE ANHYDROUSInactive
Quantity: 0.2 mg in 1 mL
Code: NVG71ZZ7P0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT