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 44.

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 8 of 14 · 528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-010	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-011	LIQUAEMIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-012	LIQUAEMIN SODIUM PRESERVATIVE FREE	5,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N000552-013	LIQUAEMIN SODIUM PRESERVATIVE FREE	10,000 UNITS/ML	INJECTABLE / INJECTION		1986-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N000552-001	LIQUAEMIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-002	LIQUAEMIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-003	LIQUAEMIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-004	LIQUAEMIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-005	LIQUAEMIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-007	LIQUAEMIN LOCK FLUSH	100 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-008	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N000552-009	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`

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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	c8c4edd2-ee9e-4558-6b8c-b83adc242a0a	2026-08-25	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Henry Schein, Inc.	45dc6b8b-ed5d-40a2-8d9c-084c863ae93a	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	239b4816-6a55-451b-bf40-e611be07d12f	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	9ea0a519-dc7c-42e3-939e-2a7c80eedd25	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	e0cc5f44-9a67-4274-a48a-d6118e96d391	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	62cfd1bb-894f-4429-b362-1e40981dccc6	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	9cd7abe6-3923-4007-8491-273ef6e05ad7	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	eede8a0c-5ae6-4166-84b3-12081405f08e	2026-05-25	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	f67eea4e-80ff-48da-8b04-8addc5cd31d1	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	0413f511-6b34-4c15-e48b-3fad08baacbe	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	32e34077-aff1-4ec7-f9b0-b8e240768fb8	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	51197aa6-de34-3a55-e063-6294a90a89c9	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Plano Pharmaceuticals Inc.	4deaa9ac-91aa-d96b-e063-6294a90a47bd	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	6c181d7e-aed2-4975-30ac-d39a94cca7ec	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	4c118b39-cb4e-31a9-e063-6394a90a41b0	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	REMEDYREPACK INC.	a5fab0b1-c472-489c-ba87-2f8e53356173	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Medical Purchasing Solutions, LLC	463e0624-b8c3-386b-e063-6294a90afd28	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	d55b4a63-0c04-4874-b74f-9e9b9e8b008c	2025-11-28	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	ed937dd2-8fab-4875-a1e8-627b71ccb7fb	2025-11-27	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