Application 019953

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes
002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes
003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	Yes	Yes
004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20
N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15
N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25
N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019953-001	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 2 · 74 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
2026-09-14 22:38:34	2026-08	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019953-003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019953-004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2025-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019953-001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019953-002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	2023-12-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N019953-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019953-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019953-001	AP	1	`a50c72e98297…`

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 in Sodium Chloride	HEPARIN SODIUM IN SODIUM CHLORIDE	B. Braun Medical Inc.	a3041c04-0ea8-4d36-81ce-c5091c906316	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019953 application number: NDA019953 ndc (product): 0264-9872
Heparin Sodium in Sodium Chloride	HEPARIN SODIUM IN SODIUM CHLORIDE	B. Braun Medical Inc.	8b030692-fc66-4c53-85aa-6f865e635618	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019953 application number: NDA019953

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-9872	Heparin Sodium in Sodium Chloride	Heparin Sodium in Sodium Chloride	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81742	SUPPL	2025-03-27
81740	SUPPL	2025-03-26
77028	SUPPL	2023-12-19
76952	SUPPL	2023-12-18
12097	SUPPL	2016-05-17
19889	SUPPL	2016-05-16
34142	SUPPL	2013-09-09
19888	SUPPL	2013-09-04
19887	SUPPL	2013-01-14
34141	SUPPL	2013-01-11
19886	SUPPL	2011-12-29
34140	SUPPL	2011-12-23
34139	SUPPL	2009-03-17
1851	SUPPL	2009-03-03
1850	SUPPL	2004-04-20