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CYANOCOBALAMIN

ANDA

CYANOCOBALAMIN | A080737 | AMERICAN REGENT INC

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$1.97

per ml

Lowest NADAC/Unit

$0.7612

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00517003225CYANOCOBALAMIN 10,000 MCG/10 ML	$1.97	ML	Generic	—	2026-06-17
68001054260CYANOCOBALAMIN 1,000 MCG/ML VL	$1.49	ML	Generic	—	2026-06-17
00517003125CYANOCOBALAMIN 1,000 MCG/ML VL	$1.49	ML	Generic	—	2026-06-17
00517013001CYANOCOBALAMIN 30,000 MCG/30 ML	$0.7612	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain3 active DMFs6 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCECYANOCOBALAMIN

DMF 40951981

HEBEI YUXING BIO-ENGINEERING CO LTDCYANOCOBALAMIN

DMF 213912008

HEBEI HUARONG PHARMACEUTICAL CO LTDCYANOCOBALAMIN

DMF 361912021

FARMITALIA SPAInactiveCYANOCOBALAMIN (VITAMIN B 12)

DMF 32221978

SANOFI CHIMIEInactiveCYANOCOBALAMIN PH. EUR. USP, JP

DMF 51381983

ANTIBIOTICE SAInactiveCYANOCOBALAMIN (VITAMIN B12)

DMF 165562003

NORTH CHINA PHARMACEUTICAL VICTOR CO LTDInactiveCYANOCOBALAMIN, USP (VITAMIN B-12)

DMF 169062003

WOCKHARDT LTDInactiveCYANOCOBALAMIN USP

DMF 197022006

HEBEI HUARONG PHARMACEUTICAL CO LTDInactiveCYANOCOBALAMIN

DMF 209732007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2021	SUPPL -40	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.