Heparin Sodium

Product NDC: 0264-5705
Requested package NDC: 0264-5705-10
11-digit product format: 002645705
Labeler code: 0264
Product ID: 0264-5705_12d0886b-aa54-417e-a235-2dce060ea52d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: B. Braun Medical Inc.
Application: ANDA208827
Marketing category: ANDA
Marketing start: 2019-04-08
Marketing end: 0000-00-00
Substance: HEPARIN SODIUM
Active strength: 5000 [USP'U]/.5mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0264-5705	0264-5705-10	D	Discontinued by firm		2026-08-17

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
A208827-001	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION			2018-11-19

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	AP	2018-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208827-001	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION		2018-11-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208827-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208827-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208827-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208827-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208827-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208827-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208827-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208827-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208827-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208827-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208827-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208827-001	AP	1	`ea1830bbd6c7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-5705-05	ML - Milliliter	0264-5705	ae4d9fc8-9f3a-4776-972e-4d773db72838	1	2019-04-11
0264-5705-10	ML - Milliliter	0264-5705	e62af1bb-2dda-4c5c-b685-0069421cdb6b	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-5705	HEPARIN SODIUM INJECTION [B. BRAUN MEDICAL INC.]	7	Legacy NDC	20221117_83c0c7c4-96ff-4e2d-85be-628bfd5ed771.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-5705-10	00264570510	10 BLISTER PACK in 1 CARTON (0264-5705-10) > 1 SYRINGE in 1 BLISTER PACK (0264-5705-05) > .5 mL in 1 SYRINGE	10 blister pack	2019-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Heparin Sodium Injection, USP Rx only	B. Braun Medical Inc.	2022-11-16	HUMAN PRESCRIPTION DRUG LABEL	7