Application 017064

Type: NDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN LOCK FLUSH	HEPARIN SODIUM	INJECTABLE; INJECTION	100 UNITS/ML	No	No
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	No	No
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
004	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	No	No
005	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	No	No
006	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	40,000 UNITS/ML	No	No
015	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	2,500 UNITS/ML	No	No
016	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	3,000 UNITS/ML	No	No
017	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	4,000 UNITS/ML	No	No
018	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	6,000 UNITS/ML	No	No
019	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	7,500 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 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N017064-002	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-003	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-004	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-005	HEPARIN SODIUM	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-006	HEPARIN SODIUM	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-015	HEPARIN SODIUM	HEPARIN SODIUM	2,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-016	HEPARIN SODIUM	HEPARIN SODIUM	3,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-017	HEPARIN SODIUM	HEPARIN SODIUM	4,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-018	HEPARIN SODIUM	HEPARIN SODIUM	6,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N017064-019	HEPARIN SODIUM	HEPARIN SODIUM	7,500 UNITS/ML	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 11 · 430 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	N017064-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-003	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-004	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-005	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-006	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-015	HEPARIN SODIUM	2,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-016	HEPARIN SODIUM	3,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-017	HEPARIN SODIUM	4,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-018	HEPARIN SODIUM	6,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017064-019	HEPARIN SODIUM	7,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017064-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-003	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-004	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-005	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-006	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-015	HEPARIN SODIUM	2,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-016	HEPARIN SODIUM	3,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-017	HEPARIN SODIUM	4,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-018	HEPARIN SODIUM	6,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017064-019	HEPARIN SODIUM	7,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017064-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-003	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-004	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-005	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-006	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-015	HEPARIN SODIUM	2,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-016	HEPARIN SODIUM	3,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-017	HEPARIN SODIUM	4,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-018	HEPARIN SODIUM	6,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017064-019	HEPARIN SODIUM	7,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-002	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-003	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-004	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-005	HEPARIN SODIUM	20,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-006	HEPARIN SODIUM	40,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-015	HEPARIN SODIUM	2,500 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-016	HEPARIN SODIUM	3,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-017	HEPARIN SODIUM	4,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-018	HEPARIN SODIUM	6,000 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017064-019	HEPARIN SODIUM	7,500 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 · 56 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	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
Heparin Sodium	HEPARIN SODIUM	Northstar Rx LLC	2edf6d35-5cf3-b7ff-e063-6394a90a4f33	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
80007	SUPPL	2024-10-28
79993	SUPPL	2024-10-25