Application 000552

Type: NDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIQUAEMIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	No	No
002	LIQUAEMIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	40,000 UNITS/ML	No	No
003	LIQUAEMIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
004	LIQUAEMIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
005	LIQUAEMIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No
007	LIQUAEMIN LOCK FLUSH	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	No	No
008	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
009	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
010	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No
011	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
012	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
013	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N000552-001	LIQUAEMIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-002	LIQUAEMIN SODIUM	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-003	LIQUAEMIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-004	LIQUAEMIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-005	LIQUAEMIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-007	LIQUAEMIN LOCK FLUSH	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-008	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-009	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-010	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11
N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11
N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11

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 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceticals	ef309d83-7262-4874-8580-f4ca254f963a	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	6d5eae7d-a5f6-411c-b589-3e5f7eecc875	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	feec2820-502f-4a97-84c9-f173729c51d3	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sagent Pharmaceuticals	8ebe4b4d-cb28-47e8-9598-6105d250b3d2	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	3a998729-c912-4e21-8e49-d1e72ba6fe9e	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Pfizer Laboratories Div Pfizer Inc	56dc3074-f1c5-45a3-b923-f1d14858e06d	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	02fb700d-a28c-4d45-b78d-382dc0d5986c	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	3edf9198-b88d-7808-e063-6394a90ae89c	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC.	3ea2bd53-ed13-a516-e063-6394a90a5dd9	2025-09-12	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	9207cef5-4cec-41e7-a351-29ba726feb44	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	07438e10-1589-4683-9f26-e5494d076cf0	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hikma Pharmaceuticals USA Inc.	7014808d-cec9-4b2c-8eb5-940493e356ab	2025-08-13	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Civica, Inc.	1e362730-5a56-4948-a90f-2cb75fed9e91	2025-07-12	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	34b8fe93-ee34-4a35-9af5-5d41705a28e9	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	c4fa6d34-e76b-4c3c-b74d-21ce41432a04	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	NorthStar RxLLC	41dd053d-49f6-4eb1-b9e7-3508ede82df8	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	a07195bc-7442-32b4-e053-2995a90a0151	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Mylan Institutional LLC	88114716-5759-4bc9-8a85-d28da12962cc	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	83a59e7d-63e9-4eb8-87f0-52039d6893a5	2025-03-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hepalink USA Inc.	c4c6bc1f-e0c7-fd0d-e053-2995a90abdef	2025-02-19	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80003	SUPPL	2024-10-28
79989	SUPPL	2024-10-25