Application 017029

Type: NDA
Sponsor: FRESENIUS KABI USA

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	Yes	Yes
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
004	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	Yes	Yes
010	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
013	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
014	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	Yes	Yes
015	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
016	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	Yes	Yes
019	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
020	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	40 UNITS/ML	Yes	No
022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	50 UNITS/ML	Yes	Yes
023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	Yes	Yes
024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	50 UNITS/ML	Yes	Yes
025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 16 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017029-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
N017029-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-004	HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28
N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22
N017029-020	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31
N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24
N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
N017029-001	AP
N017029-003	AP
N017029-004	AP
N017029-010	AP
N017029-013	AP
N017029-014	AP
N017029-015	AP
N017029-016	AP
N017029-019	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 14 · 542 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-020	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-020	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 374 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	N017029-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-013	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-014	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-015	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-016	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-019	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017029-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-013	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-014	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-015	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-016	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-019	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-013	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-014	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-015	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-016	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-019	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017029-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-013	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-014	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-015	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-016	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-019	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-010	AP	1	`fd3edfee7708…`

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 · 13 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	f67eea4e-80ff-48da-8b04-8addc5cd31d1	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 55154-9585
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-542 ndc (product): 63323-459 ndc (product): 63323-540 ndc (product): 63323-262
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-542 ndc (product): 63323-459 ndc (product): 63323-540 ndc (product): 63323-276 ndc (product): 63323-262
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-540 ndc (product): 63323-262
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	3a998729-c912-4e21-8e49-d1e72ba6fe9e	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 0404-9979
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	239b4816-6a55-451b-bf40-e611be07d12f	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 55154-9583
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	9207cef5-4cec-41e7-a351-29ba726feb44	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-118
Heparin Sodium	HEPARIN SODIUM	Phlow Corporation	cece935c-1c0a-4949-b023-d6df3d53fbfa	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	cb1c1e7a-c9ca-4a07-8833-e45ce436d287	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-522 ndc (product): 63323-518 ndc (product): 63323-517 ndc (product): 63323-523
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	971505d4-f78c-6f5d-e053-2995a90a00e0	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 51662-1409
HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM IN SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c72b193e-0687-e002-e053-2995a90a7182	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 51662-1578
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	a120bdfd-21e1-4024-82a7-13cfeed290c1	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	3facd525-b9ad-46d0-b63e-f13a5f6d591d	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 63323-262

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9979	Heparin Sodium	heparin sodium	Henry Schein, Inc.	NDA	Current
0404-9979	Heparin Sodium	heparin sodium	Henry Schein, Inc.	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1578	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM IN SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-262	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-540	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
55154-9354	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9354	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9360	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9360	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9397	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9397	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9583	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9583	Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	NDA	Current
55154-9585	Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	NDA	Current
55154-9585	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
63323-118	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-118	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-542	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-542	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80005	SUPPL	2024-10-28
79991	SUPPL	2024-10-25
68640	SUPPL	2021-09-20
67735	SUPPL	2021-06-08
63804	SUPPL	2020-07-06
63795	SUPPL	2020-07-06
56692	SUPPL	2018-12-07
56509	SUPPL	2018-11-20
49553	SUPPL	2017-08-28
49550	SUPPL	2017-08-28
13071	SUPPL	2014-04-07
13070	SUPPL	2011-12-29
33217	SUPPL	2011-12-23
13069	SUPPL	2011-07-05
10949	SUPPL	2010-06-24
530	SUPPL	2010-06-14
33216	SUPPL	2008-10-03
529	SUPPL	2008-09-26
528	SUPPL	2002-03-22