Heparin Sodium

Product NDC: 55154-8138
11-digit product format: 551548138
Labeler code: 55154
Product ID: 55154-8138_666d1845-5a05-4805-b706-43cdbaa3ecb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Heparin Sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Cardinal Health 107, LLC
Application: ANDA202957
Marketing category: ANDA
Marketing start: 2014-06-12
Marketing end: 0000-00-00
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: 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	55154-8138		D	Discontinued by firm		2026-08-11
excluded package	package	55154-8138	55154-8138-5	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55154-8138		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-8138	55154-8138-5	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202957-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP		2014-06-12
A202957-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP		2014-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202957-001	AP
A202957-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202957-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202957-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	2014-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202957-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202957-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202957-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202957-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202957-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202957-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202957-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202957-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202957-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202957-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202957-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202957-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202957-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202957-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202957-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202957-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202957-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202957-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202957-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202957-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202957-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202957-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202957-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202957-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202957-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202957-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202957-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202957-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202957-002	AP	1	`782e0a99824c…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-8138	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]	4	Legacy NDC	20240524_bf35e6b7-8796-4c9f-a971-a6b96ed047da.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	4c118b39-cb4e-31a9-e063-6394a90a41b0	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	Hepalink USA Inc.	c4c6bc1f-e0c7-fd0d-e053-2995a90abdef	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	Sandoz Inc.	1c634e53-44d6-cdcd-e063-6294a90a92e9	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957
Heparin Sodium	HEPARIN SODIUM	McKesson Corporation dba SKY Packaging	7f05762a-7527-4796-b21e-68277aec379e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202957 application number: ANDA202957

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
55154-8138-5	55154813805	5 VIAL, MULTI-DOSE in 1 BAG (55154-8138-5) > 1 mL in 1 VIAL, MULTI-DOSE	2014-06-12	0000-00-00	No	No	Current