Application 090808

Type: ANDA
Sponsor: SAGENT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No

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…`

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 ndc (product): 55154-2827
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 ndc (product): 25021-403 ndc (product): 25021-400 ndc (product): 25021-402
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 ndc (product): 25021-403 ndc (product): 25021-400 ndc (product): 25021-402
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9872	Heparin Sodium	Heparin Sodium	Henry Schein, Inc.	ANDA	Current
0404-9872	Heparin Sodium	Heparin Sodium	Henry Schein, Inc.	ANDA	Current
25021-400	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-400	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-400	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-400	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-402	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-402	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-402	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-402	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-403	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-403	Heparin Sodium	Heparin Sodium	Sagent Pharmaceticals	ANDA	Current
25021-403	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
25021-403	Heparin Sodium	Heparin Sodium	Sagent Pharmaceuticals	ANDA	Current
52584-400	HEPARIN SODIUM	heparin sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-400	HEPARIN SODIUM	heparin sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-400	HEPARIN SODIUM	heparin sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-402	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-402	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-402	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
52584-402	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	ANDA	Current
55154-2827	Heparin Sodium	Heparin Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-2827	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
55154-2827	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current