Heparin Sodium

Product NDC: 0781-3327
11-digit product format: 007813327
Labeler code: 0781
Product ID: 0781-3327_acd26ba3-bd84-48db-9824-07984dfb11df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Sandoz Inc
Application: ANDA091682
Marketing category: ANDA
Marketing start: 2011-06-08
Marketing end: 2020-04-30
Substance: HEPARIN SODIUM
Active strength: 5000 [USP'U]/mL
Pharmacologic classes: Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-3327		D	Discontinued by firm	2026-10-16
excluded package	package	0781-3327	0781-3327-95	D	Discontinued by firm	2026-10-16
excluded package	package	0781-3327	0781-3327-96	D	Discontinued by firm	2026-10-16

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 · 36 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	0781-3327-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-3327-95	`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	0781-3327-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-3327-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-3327-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-3327-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-3327-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-3327-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-3327-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-3327-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-3327-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-3327-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-3327-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-3327-95	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-3327-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-3327-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-3327-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-3327-95	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-3327-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-3327-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-3327-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-3327-95	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-3327-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-3327-95	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091682-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP		2011-06-08
A091682-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP		2011-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091682-001	AP
A091682-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091682-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091682-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2011-06-08	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091682-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091682-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091682-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091682-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091682-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091682-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091682-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091682-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091682-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091682-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091682-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091682-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091682-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091682-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091682-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091682-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091682-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091682-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091682-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091682-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091682-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091682-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091682-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091682-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091682-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091682-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091682-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091682-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091682-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091682-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091682-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091682-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091682-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091682-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091682-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091682-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091682-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091682-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091682-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091682-002	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3327-71	ML - Milliliter	0781-3327	6e24f08a-4886-4c74-b273-2176c824c527	1	2017-03-06
0781-3327-95	ML - Milliliter	0781-3327	3a1f5239-2e0d-44ce-8e09-5fd9e4a5ccbe	1	2017-03-06

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Plano Pharmaceuticals Inc.	4deaa9ac-91aa-d96b-e063-6294a90a47bd	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091682 application number: ANDA091682