Cyanocobalamin
CYANOCOBALAMININJECTION, USP
Approved
Approval ID
2fb653d6-e2b2-4969-831b-c0dc37b9c0cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 3
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 Code0517-0031
Application NumberANDA080737
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (4)
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
cyanocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0032
Application NumberANDA080737
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (4)
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
cyanocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0130
Application NumberANDA080737
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT