Is there a generic for Heparin sodium?

Yes. The FDA Orange Book lists 54 approved generic (ANDA) applications for Heparin sodium, referencing the brand HEPARIN SODIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Heparin sodium?

HEPARIN SODIUM (NDA 201370, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Heparin sodium are approved?

Heparin sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Heparin sodium

Heparin sodium: 32 brands, 54 generics; first approved Apr 28, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 54 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

236

Originator applications

Brand (NDA) products

HEPARIN SODIUMRLD

PFIZERNDA 20137020114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	—

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDRS

B BRAUNNDA 01995319924 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERRLDRS

B BRAUNNDA 01995219923 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDRS

HOSPIRANDA 018916198911 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
100 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUMRLDRS

FRESENIUS KABI USANDA 017029—16 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
20,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
20,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	—
40 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
50 UNITS/ML	INJECTABLE	INJECTION	Rx	—
100 UNITS/ML	INJECTABLE	INJECTION	Rx	—
50 UNITS/ML	INJECTABLE	INJECTION	Rx	—
100 UNITS/ML	INJECTABLE	INJECTION	Rx	—

HEPARIN SODIUMRLDRS

FRESENIUS KABI USANDA 017651—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUMRLD

HIKMANDA 017007—8 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
7,500 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
15,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
2,500 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUMRLDRS

HIKMANDA 017037—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/0.5ML	INJECTABLE	INJECTION	Rx	—

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUNNDA 01980219924 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRANDA 01980519892 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

SODIUM HEPARIN

BAXTER HLTHCARENDA 0170361988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 01881419854 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
2,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUNNDA 01904219853 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
200 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUNNDA 0191341985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUNNDA 0191351985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRANDA 01933919854 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%

HOSPIRANDA 01891119859 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
100 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAWNDA 01913019843 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—
200 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 01860919823 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
500 UNITS/100ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN LOCK FLUSH

HOSPIRANDA 005264—8 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
100 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
2,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
2,500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN LOCK FLUSH

PARKE DAVISNDA 017346—6 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
7,500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

ABRAXIS PHARMNDA 017033—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

ABRAXIS PHARMNDA 017979—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

ASPEN GLOBAL INCNDA 000552—12 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
100 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

CHAMBERLIN PARENTERLNDA 017130—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

DELL LABSNDA 017540—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

DR REDDYSNDA 017064—10 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
2,500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
3,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
4,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
6,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
7,500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

EPIC PHARMA LLCNDA 017486—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

LILLYNDA 005521—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

PHARM SPECNDA 017780—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

PHARMACIA AND UPJOHNNDA 004570—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

LIPO-HEPIN

3MNDA 017027—11 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—
40,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
7,500 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—
15,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (54)

HEPARIN SODIUM

BE PHARMSANDA 2148042020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

BE PHARMSANDA 2148392020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

FRESENIUS KABI USAANDA 21244120202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP
200 UNITS/100ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

EMERGE BIOSCIENCEANDA 2120612020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM PRESERVATIVE FREE

EMERGE BIOSCIENCEANDA 2120602020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

EMERGE BIOSCIENCEANDA 2110042020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

GLANDANDA 20532320192 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

EMERGE BIOSCIENCEANDA 21100720193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

EMERGE BIOSCIENCEANDA 2110052018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

B BRAUN MEDICALANDA 2088272018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

PHARMOBEDIENTANDA 20385120173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

PHARMOBEDIENTANDA 2038522017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

FRESENIUS KABI USAANDA 2065522016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

SHENZHEN TECHDOWANDA 20295720142 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

SHENZHEN TECHDOWANDA 2027332014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

SHENZHEN TECHDOWANDA 20319820142 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
20,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM PRESERVATIVE FREE

SHENZHEN TECHDOWANDA 2027322014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

CASI PHARMS INCANDA 0916592011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

PLANO PHARMSANDA 09168220112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

PLANO PHARMSANDA 2010022011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

SAGENT PHARMSANDA 09080820103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

SAGENT PHARMSANDA 0908092010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM PRESERVATIVE FREE

SAGENT PHARMSANDA 0908102010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

HOSPIRA INCANDA 09057120093 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM

HOSPIRAANDA 0400951996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

DR REDDYSANDA 0400071996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

WATSON LABS INCANDA 0400081995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM PRESERVATIVE FREE

HOSPIRAANDA 0895221987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Rx	AP

HEPARIN SODIUM PRESERVATIVE FREE

DR REDDYSANDA 0894641986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN LOCK FLUSH

LUITPOLDANDA 0890631985

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

HEPARIN LOCK FLUSH

LUITPOLDANDA 0890641985

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0885801984

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0885811984

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

HEPARIN LOCK FLUSH

SOLOPAKANDA 0884571984

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0884581984

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0884601984

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

HEPARIN LOCK FLUSH

SOLOPAKANDA 0884591984

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

HEPARIN SODIUM

SMITH AND NEPHEWANDA 0882391984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

LUITPOLDANDA 0874521983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

HOSPIRAANDA 0880991983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2,500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUMRS

HOSPIRAANDA 0881001983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Rx	—

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0879041983

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0879581983

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0879061983

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

HEPARIN LOCK FLUSH

SMITH AND NEPHEWANDA 0879591983

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

HEPARIN LOCK FLUSH

SOLOPAKANDA 0879031983

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

HEPARIN LOCK FLUSH

SOLOPAKANDA 0879051983

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

HEPARIN LOCK FLUSH

INTL MEDICATIONANDA 086357—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—
500 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

SOLOPAKANDA 087043—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

SOLOPAKANDA 087077—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

SOLOPAKANDA 087395—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

SOLOPAKANDA 087107—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM

SOLOPAKANDA 087363—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10,000 UNITS/0.5ML	INJECTABLE	INJECTION	Discontinued	—

HEPARIN SODIUM PRESERVATIVE FREE

PHARMA SERVE NYANDA 086129—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1,000 UNITS/ML	INJECTABLE	INJECTION	Discontinued	—

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Apr 28, 1982

44 yr 10 mo ago

Most recent approval

Mar 25, 2025

1 yr 4 mo ago

Approvals span 1982–2025 across 86 FDA applications.

Brand (NDA) 3237%

Generic (ANDA) 5463%

Heparin sodium — 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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