Heparin Sodium

Product NDC: 67457-385
11-digit product format: 674570385
Labeler code: 67457
Product ID: 67457-385_5f849fd9-978e-4ce4-9b58-f42bc6babcd5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Mylan Institutional LLC
Application: ANDA203851
Marketing category: ANDA
Marketing start: 2018-03-16
Marketing end: 0000-00-00
Substance: HEPARIN SODIUM
Active strength: 1000 [USP'U]/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67457-385		D	Discontinued by firm		2026-10-15
excluded package	package	67457-385	67457-385-99	D	Discontinued by firm		2026-10-15

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

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
A203851-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30
A203851-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30
A203851-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203851-001	AP
A203851-002	AP
A203851-003	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 · 132 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	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203851-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203851-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203851-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2017-11-30	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203851-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203851-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203851-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203851-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203851-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203851-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203851-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203851-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203851-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203851-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203851-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203851-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203851-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203851-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203851-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203851-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203851-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203851-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203851-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203851-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203851-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203851-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203851-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203851-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203851-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203851-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203851-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203851-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203851-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203851-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203851-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203851-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203851-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203851-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203851-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203851-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203851-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203851-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203851-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203851-002	AP	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac74f96-3910-44b9-8551-036880fbb1fb	Product name	1	20260108
0a18eae4-4259-42db-86b6-915f66e83b06	Product name	1	20250729
2c999b01-2a13-4eff-8eb4-00b87316ef79	Product name	1	20231116
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-385-10	Heparin Sodium	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10		10
67457-385-99	Heparin Sodium	25 in 1 CARTON	INJECTION	25		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-385-10	ML - Milliliter	67457-385	bbb3948a-3b02-4198-bc7a-82558e5aad17	1	2018-04-19
67457-385-99	ML - Milliliter	67457-385	4d13b983-f2ee-4a56-ad49-bffed4afc3f8	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-385	HEPARIN SODIUM INJECTION [MYLAN INSTITUTIONAL LLC]	10	Legacy NDC, 2 package rows	20250501_88114716-5759-4bc9-8a85-d28da12962cc.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	PSN	88114716-5759-4bc9-8a85-d28da12962cc	10
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	88114716-5759-4bc9-8a85-d28da12962cc	10
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	PSN	88114716-5759-4bc9-8a85-d28da12962cc	10
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	88114716-5759-4bc9-8a85-d28da12962cc	10
1362831	heparin sodium, porcine 10000 UNT/ML Injectable Solution	SCD	88114716-5759-4bc9-8a85-d28da12962cc	10
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	SCD	88114716-5759-4bc9-8a85-d28da12962cc	10
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	SY	88114716-5759-4bc9-8a85-d28da12962cc	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-385-10	67457038510	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
67457-385-99	67457038599	25 VIAL, MULTI-DOSE in 1 CARTON (67457-385-99) > 10 mL in 1 VIAL, MULTI-DOSE (67457-385-10)		2018-03-16	0000-00-00	No	No	Current