Heparin Sodium

Product NDC: 0404-9872
11-digit product format: 004049872
Labeler code: 0404
Product ID: 0404-9872_857a8443-d356-42b7-a0c1-c1a261e33b57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: ANDA090808
Marketing category: ANDA
Marketing start: 2022-01-11
Substance: HEPARIN SODIUM
Active strength: 5000 [USP'U]/mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090808-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30
A090808-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30
A090808-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090808-001	AP
A090808-002	AP
A090808-003	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090808-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2010-06-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090808-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090808-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090808-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090808-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090808-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090808-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090808-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090808-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090808-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090808-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090808-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090808-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090808-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090808-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090808-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090808-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090808-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090808-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090808-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090808-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090808-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090808-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Heparin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HEPARIN SODIUM	5000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZZ45AB24CA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1659263	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac74f96-3910-44b9-8551-036880fbb1fb	Product name	1	20260108
0a18eae4-4259-42db-86b6-915f66e83b06	Product name	1	20250729
2c999b01-2a13-4eff-8eb4-00b87316ef79	Product name	1	20231116
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9872-01	Heparin Sodium	1 in 1 BAG	INJECTION, SOLUTION	1		5
0404-9872-01	Heparin Sodium	1 mL in 1 VIAL	INJECTION, SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9872	HEPARIN SODIUM INJECTION, SOLUTION [HENRY SCHEIN, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240616_45dc6b8b-ed5d-40a2-8d9c-084c863ae93a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	e0cc5f44-9a67-4274-a48a-d6118e96d391	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090808 application number: ANDA090808
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	463e0624-b8c3-386b-e063-6294a90afd28	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090808 application number: ANDA090808
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceticals	ef309d83-7262-4874-8580-f4ca254f963a	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090808 application number: ANDA090808
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	8ebe4b4d-cb28-47e8-9598-6105d250b3d2	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090808 application number: ANDA090808
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	2025-10-31	Adverse reactions	Exact identifier application applno (ANDA): 090808 application number: ANDA090808 ndc (product): 0404-9872

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZZ45AB24CA	HEPARIN SODIUM	9041-08-1	HEPARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659263	heparin sodium, porcine 5000 UNT in 1 ML Injection	PSN	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	5
1659263	1 ML heparin sodium, porcine 5000 UNT/ML Injection	SCD	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	5
1659263	heparin sodium, porcine 5000 UNT per 1 ML Injection	SY	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9872-01	00404987201	1 VIAL in 1 BAG (0404-9872-01) / 1 mL in 1 VIAL	1 vial	2022-01-11	0000-00-00	No	No	Current