FDA Product

cyanocobalamine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

cyanocobalamine

FDA Product Code

67457-400

Regulatory Information

NDC Product Code

67457-400

Application Number

ANDA204829

Marketing Category

C73584

Effective Date

July 6, 2017

Territorial Authority

USA

FDA Title

Cyanocobalamin Injection, USP (1,000 mcg/mL) Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerMylan Institutional LLC

DUNS Number

790384502

Active Ingredients

Quantity: 1000 ug in 1 mL

Code: P6YC3EG204

Class Code: ACTIB

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CYANOCOBALAMIN

Code: P6YC3EG204

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