Heparin Sodium

Product NDC: 71288-424
11-digit product format: 712880424
Labeler code: 71288
Product ID: 71288-424_62adb621-cc86-4702-8ba2-0fabedf075f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA211007
Marketing category: ANDA
Marketing start: 2019-06-15
Marketing end: 0000-00-00
Substance: HEPARIN SODIUM
Active strength: 10000 [USP'U]/mL
Pharmacologic classes: Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71288-424		D	Discontinued by firm		2026-09-14
excluded package	package	71288-424	71288-424-96	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71288-424-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71288-424-96	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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
A211007-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28
A211007-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28
A211007-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211007-001	AP
A211007-002	AP
A211007-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211007-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2019-05-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211007-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211007-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211007-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211007-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211007-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211007-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211007-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211007-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211007-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211007-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211007-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211007-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211007-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211007-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211007-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211007-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211007-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211007-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211007-001	AP	1	`301d65b070ca…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-424-95	ML - Milliliter	71288-424	17f1eb63-644c-42d2-8d5b-95a5545fb321	1	2020-06-05
71288-424-96	ML - Milliliter	71288-424	9818167b-f5fe-4547-bee5-91d7faefd230	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-424	HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]	2	Legacy NDC	20211124_b6212d9b-d82b-46ea-9ba1-5410d04e0816.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	02fb700d-a28c-4d45-b78d-382dc0d5986c	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	3edf9198-b88d-7808-e063-6394a90ae89c	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC.	3ea2bd53-ed13-a516-e063-6394a90a5dd9	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	c4fa6d34-e76b-4c3c-b74d-21ce41432a04	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211007 application number: ANDA211007

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	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-424-96	71288042496	25 VIAL, SINGLE-DOSE in 1 CARTON (71288-424-96) > 1 mL in 1 VIAL, SINGLE-DOSE (71288-424-95)	2019-06-15	0000-00-00	No	No	Current