Heparin Sodium

Product NDC: 81565-203
11-digit product format: 815650203
Labeler code: 81565
Product ID: 81565-203_4bebb181-0ed2-44b0-af0d-4802862e73b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HEPARIN SODIUM
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Phlow Corporation
Application: NDA017029
Marketing category: NDA
Marketing start: 2022-03-07
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 16 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017029-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
N017029-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-004	HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28
N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05
N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22
N017029-020	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31
N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24
N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24
N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
N017029-001	AP
N017029-003	AP
N017029-004	AP
N017029-010	AP
N017029-013	AP
N017029-014	AP
N017029-015	AP
N017029-016	AP
N017029-019	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 14 · 542 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-020	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-016	HEPARIN SODIUM IN PLASTIC CONTAINER	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-019	HEPARIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	2010-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-020	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2011-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	40 UNITS/ML	INJECTABLE / INJECTION		RLD	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	50 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION		RLD, RS	2017-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-002	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-004	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-010	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1986-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-013	HEPARIN SODIUM IN PLASTIC CONTAINER	1,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-014	HEPARIN SODIUM IN PLASTIC CONTAINER	5,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-015	HEPARIN SODIUM IN PLASTIC CONTAINER	10,000 UNITS/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-05	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 374 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017029-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-013	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-014	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-015	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-016	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017029-019	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017029-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-013	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-014	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-015	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-016	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017029-019	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-013	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-014	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-015	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-016	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017029-019	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017029-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-013	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-014	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-015	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-016	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017029-019	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017029-010	AP	1	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: Heparin Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HEPARIN SODIUM	1000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZZ45AB24CA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1361226	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cece935c-1c0a-4949-b023-d6df3d53fbfa	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81565-203-02	2024-02-22	C162847	48780-1	1030e365-63e5-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use Initial U.S. Approval: 1939
81565-203-02	2024-01-30	C162847	48780-1	1030e365-63e5-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81565-203-01	Heparin Sodium	10 mL in 1 VIAL	INJECTION, SOLUTION	10		3
81565-203-02	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81565-203-01	ML - Milliliter	81565-203	150fb848-df29-43c3-ba4f-d1115caf7421	1	2025-10-14
81565-203-02	ML - Milliliter	81565-203	4cf12303-a7d5-4b69-8e2e-28c8a4e04c60	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81565-203	HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [PHLOW CORPORATION]	3	Current NDC, Legacy NDC, 2 package rows	20240522_cece935c-1c0a-4949-b023-d6df3d53fbfa.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	f67eea4e-80ff-48da-8b04-8addc5cd31d1	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	3a998729-c912-4e21-8e49-d1e72ba6fe9e	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	239b4816-6a55-451b-bf40-e611be07d12f	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	9207cef5-4cec-41e7-a351-29ba726feb44	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Phlow Corporation	cece935c-1c0a-4949-b023-d6df3d53fbfa	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029 ndc (product): 81565-203
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	cb1c1e7a-c9ca-4a07-8833-e45ce436d287	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	971505d4-f78c-6f5d-e053-2995a90a00e0	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM IN SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c72b193e-0687-e002-e053-2995a90a7182	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	a120bdfd-21e1-4024-82a7-13cfeed290c1	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	3facd525-b9ad-46d0-b63e-f13a5f6d591d	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017029 application number: NDA017029

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
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	cece935c-1c0a-4949-b023-d6df3d53fbfa	3
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	cece935c-1c0a-4949-b023-d6df3d53fbfa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81565-203-01	81565020301	10 mL in 1 VIAL	10 ml					Historical
81565-203-02	81565020302	25 VIAL in 1 TRAY (81565-203-02) / 10 mL in 1 VIAL (81565-203-01)	25 vial	2022-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Heparin Sodium	Phlow Corporation \| Fresenius Kabi USA, LLC	2024-05-16	HUMAN PRESCRIPTION DRUG LABEL	3