Application 088100

Type: ANDA
Sponsor: HOSPIRA

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088100-001	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		RS	1983-04-28

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088100-001	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RS	1983-04-28	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	c8c4edd2-ee9e-4558-6b8c-b83adc242a0a	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088100 application number: ANDA088100 ndc (product): 0409-1402
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9a5549ae-527a-1b83-e053-2a95a90a133d	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088100 application number: ANDA088100 ndc (product): 51662-1460

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
0409-1402	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	ANDA	Current
51662-1460	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1460	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-6996	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
55154-6996	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current
55154-6996	Heparin Sodium	Heparin Sodium	Cardinal Health	ANDA	Current