Heparin Sodium

Product NDC: 63323-540
11-digit product format: 633230540
Labeler code: 63323
Product ID: 63323-540_529104c9-6154-4428-953d-5546875f32e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HEPARIN SODIUM
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA017029
Marketing category: NDA
Marketing start: 1972-02-22
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	63323-540	63323-540-01	D	Discontinued by firm	2026-08-17
excluded package	package	63323-540	63323-540-11	D	Discontinued by firm	2026-08-17
excluded package	package	63323-540	63323-540-31	D	Discontinued by firm	2026-08-17
excluded package	package	63323-540	63323-540-57	D	Discontinued by firm	2026-08-17

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HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1361226	Internal RxNorm lookup
1361574	Internal RxNorm lookup
1361615	Internal RxNorm lookup
1362831	Internal RxNorm lookup
1658634	Internal RxNorm lookup
1658647	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
d55b4a63-0c04-4874-b74f-9e9b9e8b008c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-540-01	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	13
63323-540-01	Heparin Sodium	1 mL in 1 VIAL	INJECTION, SOLUTION	1	13
63323-540-11	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	13
63323-540-11	Heparin Sodium	10 mL in 1 VIAL	INJECTION, SOLUTION	10	13
63323-540-31	Heparin Sodium	30 mL in 1 VIAL	INJECTION, SOLUTION	30	13
63323-540-31	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	13
63323-540-07	Heparin Sodium	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	8
63323-540-57	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	8
63323-540-57	Heparin Sodium	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	8
63323-540-67	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	8
63323-540-03	Heparin Sodium	1 mL in 1 VIAL	INJECTION, SOLUTION	1	6
63323-540-05	Heparin Sodium	10 mL in 1 VIAL	INJECTION, SOLUTION	10	6
63323-540-13	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-540-15	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-540-33	Heparin Sodium	30 mL in 1 VIAL	INJECTION, SOLUTION	30	6
63323-540-36	Heparin Sodium	25 in 1 TRAY	INJECTION, SOLUTION	25	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-540-01	ML - Milliliter	63323-540	024fa552-6204-4e77-9f6e-4c0684f51dbb	1	2012-07-24
63323-540-05	ML - Milliliter	63323-540	ee4e1b04-6190-4ea0-ab56-4f8ffc7dbbaf	1	2020-03-10
63323-540-07	ML - Milliliter	63323-540	f293c8c8-01d1-4d7c-995c-dd999fb6121a	1	2020-05-08
63323-540-11	ML - Milliliter	63323-540	d5968e33-0e69-4f64-b3b5-53f3cfe76362	1	2012-07-24
63323-540-15	ML - Milliliter	63323-540	21eb9286-76c6-4ece-b3e3-48758576b3da	1	2020-03-10
63323-540-31	ML - Milliliter	63323-540	96e8f5c0-dd25-47fd-8605-2ebae9ca7dda	1	2012-07-24
63323-540-33	ML - Milliliter	63323-540	d9e2a1ea-d2a9-4a0d-961c-ebb9b5bf4d1a	1	2020-03-10
63323-540-36	ML - Milliliter	63323-540	3bc1d874-e02b-455f-852c-ca7b99c07b8a	1	2020-03-10
63323-540-57	ML - Milliliter	63323-540	d928465d-a023-4c61-92a6-7567726a7858	1	2012-07-24
63323-540-67	ML - Milliliter	63323-540	e86a3f10-7c2b-44e5-99aa-b7f63776425f	1	2020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HEPARIN SODIUM	ACTIVE INGREDIENT	ZZ45AB24CA	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
HEPARIN	ACTIVE MOIETY	T2410KM04A	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]	14
HEPARIN SODIUM	ACTIVE INGREDIENT	ZZ45AB24CA	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
HEPARIN	ACTIVE MOIETY	T2410KM04A	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	9
HEPARIN SODIUM	ACTIVE INGREDIENT	ZZ45AB24CA	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
HEPARIN	ACTIVE MOIETY	T2410KM04A	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
Heparin Sodium	ACTIVE INGREDIENT	ZZ45AB24CA	HEPARIN SODIUM INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Heparin	ACTIVE MOIETY	T2410KM04A	HEPARIN SODIUM INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-540	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	12	Current NDC, Legacy NDC, 6 package rows	20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip
63323-540	HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 4 package rows	20211003_ed937dd2-8fab-4875-a1e8-627b71ccb7fb.zip
63323-540	HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC, 6 package rows	20220129_2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5.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 ndc (product): 63323-540
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 ndc (product): 63323-540
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 ndc (product): 63323-540
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
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
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361574	heparin sodium, porcine 20,000 UNT/ML Injectable Solution	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658647	heparin sodium, porcine 2000 UNT in 2 ML Injection	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658634	heparin sodium, porcine 5000 UNT in 0.5 mL Injection	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	PSN	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658634	0.5 ML heparin sodium, porcine 10000 UNT/ML Injection	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658647	2 ML heparin sodium, porcine 1000 UNT/ML Injection	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1362831	heparin sodium, porcine 10000 UNT/ML Injectable Solution	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361574	heparin sodium, porcine 20000 UNT/ML Injectable Solution	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	SCD	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	SY	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361574	heparin sodium, porcine 20,000 UNT/ML Injectable Solution	SY	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658647	heparin sodium, porcine 2000 UNT per 2 ML Injection	SY	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1658634	heparin sodium, porcine 5000 UNT per 0.5 ML Injection	SY	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	13
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	8
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	PSN	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	8
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	8
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	SCD	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	8
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	PSN	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361574	heparin sodium, porcine 20,000 UNT/ML Injectable Solution	PSN	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1658634	heparin sodium, porcine 5000 UNT in 0.5 mL Injection	PSN	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	PSN	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1658634	0.5 ML heparin sodium, porcine 10000 UNT/ML Injection	SCD	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1362831	heparin sodium, porcine 10000 UNT/ML Injectable Solution	SCD	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361574	heparin sodium, porcine 20000 UNT/ML Injectable Solution	SCD	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361615	heparin sodium, porcine 5000 UNT/ML Injectable Solution	SCD	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1362831	heparin sodium, porcine 10,000 UNT/ML Injectable Solution	SY	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361574	heparin sodium, porcine 20,000 UNT/ML Injectable Solution	SY	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1658634	heparin sodium, porcine 5000 UNT per 0.5 ML Injection	SY	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	6
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	3a998729-c912-4e21-8e49-d1e72ba6fe9e	5
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	3a998729-c912-4e21-8e49-d1e72ba6fe9e	5
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	239b4816-6a55-451b-bf40-e611be07d12f	4
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	239b4816-6a55-451b-bf40-e611be07d12f	4
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	PSN	631dc216-df9e-4126-b59e-c8079ba6e287	2
1361226	heparin sodium, porcine 1000 UNT/ML Injectable Solution	SCD	631dc216-df9e-4126-b59e-c8079ba6e287	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-540-01	63323054001	25 VIAL in 1 TRAY (63323-540-01) > 1 mL in 1 VIAL	25 vial	1999-09-27	0000-00-00	No	No	Current
63323-540-03	63323054003	1 mL in 1 VIAL	1 ml					Historical
63323-540-05	63323054005	10 mL in 1 VIAL	10 ml					Historical
63323-540-07	63323054007	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
63323-540-11	63323054011	25 VIAL in 1 TRAY (63323-540-11) > 10 mL in 1 VIAL	25 vial	1999-09-27	0000-00-00	No	No	Current
63323-540-13	63323054013	25 VIAL in 1 TRAY (63323-540-13) / 1 mL in 1 VIAL (63323-540-03)	25 vial	2019-11-04	0000-00-00	No	No	Current
63323-540-15	63323054015	25 VIAL in 1 TRAY (63323-540-15) / 10 mL in 1 VIAL (63323-540-05)	25 vial	2019-11-04	0000-00-00	No	No	Current
63323-540-31	63323054031	25 VIAL in 1 TRAY (63323-540-31) > 30 mL in 1 VIAL	25 vial	1999-09-27	0000-00-00	No	No	Current
63323-540-33	63323054033	30 mL in 1 VIAL	30 ml					Historical
63323-540-36	63323054036	25 VIAL in 1 TRAY (63323-540-36) / 30 mL in 1 VIAL (63323-540-33)	25 vial	2019-11-04	0000-00-00	No	No	Current
63323-540-57	63323054057	25 VIAL, MULTI-DOSE in 1 TRAY (63323-540-57) > 10 mL in 1 VIAL, MULTI-DOSE		1999-09-27	0000-00-00	No	No	Current
63323-540-67	63323054067	25 VIAL, MULTI-DOSE in 1 TRAY (63323-540-67) / 10 mL in 1 VIAL, MULTI-DOSE (63323-540-07)		2020-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Heparin Sodium	Fresenius Kabi USA, LLC	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	6
Heparin Sodium Injection USP	Fresenius Kabi USA, LLC	2025-11-28	HUMAN PRESCRIPTION DRUG LABEL	13
Heparin Sodium Injection, USP	Fresenius Kabi USA, LLC	2025-11-27	HUMAN PRESCRIPTION DRUG LABEL	8
Heparin Sodium	Henry Schein, Inc.	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	5
Heparin Sodium	Cardinal Health 107, LLC	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	4
Heparin Sodium	General Injectables and Vaccines, Inc.	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	4
Heparin Sodium Injection USP	Cardinal Health	2020-07-10	HUMAN PRESCRIPTION DRUG LABEL	17
Heparin Sodium 1000 un/mL Injection, USP 1 mL Multi Dose Vial	General Injectables & Vaccines, Inc	2017-01-16	HUMAN PRESCRIPTION DRUG LABEL	2