Is there a generic for Cyanocobalamin?

Yes. The FDA Orange Book lists 36 approved generic (ANDA) applications for Cyanocobalamin, referencing the brand NASCOBAL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cyanocobalamin?

NASCOBAL (NDA 021642, ENDO OPERATIONS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Cyanocobalamin are approved?

Cyanocobalamin is approved in the following dosage forms: gel, metered, injectable, spray, metered, tablet.

FDA Orange Book · active-ingredient family

Cyanocobalamin

Cyanocobalamin: 9 brands, 36 generics; first approved Nov 10, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 36 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

NASCOBALRLD
ENDO OPERATIONSNDA 0216422005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/SPRAY SPRAY, METERED NASAL Discontinued —
RUBRAMIN PCRLD
BRISTOL MYERS SQUIBBNDA 006799—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Discontinued —
CALOMIST
PH HEALTHNDA 0221022007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MCG/SPRAY SPRAY, METERED NASAL Discontinued —
NASCOBAL
ENDO OPERATIONSNDA 0197221996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/INH GEL, METERED NASAL Discontinued —
BERUBIGEN
PHARMACIA AND UPJOHNNDA 006798—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
WARNER CHILCOTTNDA 007085—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
REDISOL
MERCKNDA 006668—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MCG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/INH	GEL, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

RUBIVITE

BEL MARNDA 010791—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.1MG/ML	INJECTABLE	INJECTION	Discontinued	—
1MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.03MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.12MG/ML	INJECTABLE	INJECTION	Discontinued	—

VI-TWEL
BAYER HLTHCARENDA 007012—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (36)

Abbreviated applications

CYANOCOBALAMIN
ASPIROANDA 2198202026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
MEITHEALANDA 2143162024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
MANKIND PHARMAANDA 2178392024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
LUPINANDA 2106292023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/SPRAY SPRAY, METERED NASAL Rx AB
CYANOCOBALAMIN
SAGENT PHARMS INCANDA 2151072022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
SOLA PHARMSANDA 2154172022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
ZYDUS PHARMSANDA 2146552022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
XIROMEDANDA 2150462021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
SANDOZANDA 2129152021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
EUGIA PHARMAANDA 2138742020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
GLANDANDA 2143902020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMINRS
PADAGIS ISRAELANDA 2124582020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/SPRAY SPRAY, METERED NASAL Rx AB
CYANOCOBALAMIN
SOMERSET THERAPS LLCANDA 2094292018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
VITRUVIAS THERAPANDA 2092552018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
PHARMOBEDIENTANDA 2048292017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
SOMERSET THERAPS LLCANDA 2065032015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
MYLAN INSTITUTIONALANDA 0404512003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
SOLOPAKANDA 0875511984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
EPIC PHARMA LLCANDA 0879691983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
BETALIN 12
LILLYANDA 080855—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Discontinued —
COBAVITE
WATSON LABSANDA 083013—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
COBAVITE
WATSON LABSANDA 083064—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

CYANOCOBALAMIN

ABRAXIS PHARMANDA 080510—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/ML	INJECTABLE	INJECTION	Discontinued	—
1MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.03MG/ML	INJECTABLE	INJECTION	Discontinued	—

CYANOCOBALAMINRLDRS
AM REGENTANDA 080737—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

CYANOCOBALAMIN

DELL LABSANDA 080689—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.1MG/ML	INJECTABLE	INJECTION	Discontinued	—
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

CYANOCOBALAMIN
DR REDDYSANDA 080573—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
0.1MG/ML INJECTABLE INJECTION Discontinued —
VIBISONERLDRS
FRESENIUS KABI USAANDA 080557—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
LUITPOLDANDA 080668—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
LYPHOMEDANDA 083075—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
SANOFI AVENTIS USANDA 080564—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
WATSON LABSANDA 083120—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
WEST-WARD PHARMS INTANDA 080515—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
CYANOCOBALAMIN
WYETH AYERSTANDA 080554—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML INJECTABLE INJECTION Discontinued —
1MG/ML INJECTABLE INJECTION Discontinued —
DODEX
ACCORD HLTHCAREANDA 083022—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
RUVITE
SAVAGE LABSANDA 080570—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
CYANOCOBALAMIN
WEST WARDANDA 084264—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Nov 10, 1983

43 yr 4 mo ago

Most recent approval

Jul 08, 2026

27 d ago

Approvals span 1983–2026 across 45 FDA applications.

Brand (NDA) 920%

Generic (ANDA) 3680%

Cyanocobalamin: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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