cyanocobalamin
Cyanocobalamin Injection USP 1000 mcg/mL
Approved
Approval ID
41ac0dc1-0a71-4c69-8e25-ba838f5f16a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cyanocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-005
Application NumberANDA206503
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (6)
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 15 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
cyanocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-172
Application NumberANDA206503
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (6)
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 15 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT