Application 017027

Type: NDA
Sponsor: 3M

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/0.5ML	No	No
002	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/0.5ML	No	No
003	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/0.5ML	No	No
004	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/0.5ML	No	No
005	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	40,000 UNITS/ML	No	No
006	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
007	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	No	No
008	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
009	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No
010	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	7,500 UNITS/0.5ML	No	No
011	LIPO-HEPIN	HEPARIN SODIUM	INJECTABLE;INJECTION	15,000 UNITS/0.5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N017027-001	LIPO-HEPIN	HEPARIN SODIUM	1,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982
N017027-002	LIPO-HEPIN	HEPARIN SODIUM	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982
N017027-003	LIPO-HEPIN	HEPARIN SODIUM	10,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982
N017027-004	LIPO-HEPIN	HEPARIN SODIUM	20,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982
N017027-005	LIPO-HEPIN	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017027-006	LIPO-HEPIN	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017027-007	LIPO-HEPIN	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017027-008	LIPO-HEPIN	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017027-009	LIPO-HEPIN	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017027-010	LIPO-HEPIN	HEPARIN SODIUM	7,500 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982
N017027-011	LIPO-HEPIN	HEPARIN SODIUM	15,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982

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 12 · 473 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017027-001	LIPO-HEPIN	1,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-002	LIPO-HEPIN	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-003	LIPO-HEPIN	10,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-004	LIPO-HEPIN	20,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-005	LIPO-HEPIN	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-006	LIPO-HEPIN	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-007	LIPO-HEPIN	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-008	LIPO-HEPIN	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-009	LIPO-HEPIN	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-010	LIPO-HEPIN	7,500 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017027-011	LIPO-HEPIN	15,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017027-001	LIPO-HEPIN	1,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-002	LIPO-HEPIN	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-003	LIPO-HEPIN	10,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-004	LIPO-HEPIN	20,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-005	LIPO-HEPIN	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-006	LIPO-HEPIN	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-007	LIPO-HEPIN	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-008	LIPO-HEPIN	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-009	LIPO-HEPIN	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-010	LIPO-HEPIN	7,500 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017027-011	LIPO-HEPIN	15,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017027-001	LIPO-HEPIN	1,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-002	LIPO-HEPIN	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-003	LIPO-HEPIN	10,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-004	LIPO-HEPIN	20,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-005	LIPO-HEPIN	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-006	LIPO-HEPIN	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-007	LIPO-HEPIN	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-008	LIPO-HEPIN	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-009	LIPO-HEPIN	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-010	LIPO-HEPIN	7,500 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017027-011	LIPO-HEPIN	15,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-001	LIPO-HEPIN	1,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-002	LIPO-HEPIN	5,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-003	LIPO-HEPIN	10,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-004	LIPO-HEPIN	20,000 UNITS/0.5ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-005	LIPO-HEPIN	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-006	LIPO-HEPIN	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017027-007	LIPO-HEPIN	20,000 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 3 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	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	2025-02-19	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Sandoz Inc.	1c634e53-44d6-cdcd-e063-6294a90a92e9	2025-02-19	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	7df6c90c-3b55-4bb6-8a72-6e6a6aca4e7c	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	57f1ec87-8a7d-41da-b8b8-9ecc8601c60f	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	McKesson Corporation dba SKY Packaging	7f05762a-7527-4796-b21e-68277aec379e	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9bd0f982-30f4-4e38-e053-2a95a90a3e15	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	9a5549ae-527a-1b83-e053-2a95a90a133d	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Meitheal Pharmaceuticals Inc.	ad0f410c-6121-43f9-9844-943472961cb0	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	BE Pharmaceuticals Inc.	295ea9c6-d08c-40f0-a908-de0fdac44644	2024-10-30	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	BE Pharmaceuticals Inc.	6be171fb-c85f-4336-a88d-b4d97bb0fe03	2024-10-30	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Phlow Corporation	cece935c-1c0a-4949-b023-d6df3d53fbfa	2024-05-16	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	25b0ba06-3274-4a3f-8c39-42d13764ecdf	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	cb1c1e7a-c9ca-4a07-8833-e45ce436d287	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	971505d4-f78c-6f5d-e053-2995a90a00e0	2024-01-29	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	a120bdfd-21e1-4024-82a7-13cfeed290c1	2024-01-05	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	0d929726-76c3-48fc-b4e7-fd06409f9fb3	2022-01-03	Warnings, Adverse reactions	Name fallback generic name: HEPARIN SODIUM
Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	3facd525-b9ad-46d0-b63e-f13a5f6d591d	2021-09-01	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.