MedPath

Cyanocobalamin

Cyanocobalamin Injection USP 1000 mcg/mL

Approved
Approval ID

2117af8a-723f-4e2f-98a6-83ad2c423751

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers
FDA

Vitruvias Therapeutics

DUNS: 079200795

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 Code69680-113
Application NumberANDA209255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 19, 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 Code69680-121
Application NumberANDA209255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 19, 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 Code69680-112
Application NumberANDA209255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 19, 2023
FDA Product Classification

INGREDIENTS (4)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
CyanocobalaminActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT

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Cyanocobalamin - FDA Drug Approval Details