Application 018916

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/100ML	No	No
002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	No	No
003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No
004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	No	No
005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	No	No
006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No
007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No
008	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	No	No
009	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No
010	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes
011	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes

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	TE codes	RLD / RS	Approval date
N018916-001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	1,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31
N018916-002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31
N018916-003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31
N018916-004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	100 UNITS/ML	INJECTABLE / INJECTION			1984-01-31
N018916-005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31
N018916-006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31
N018916-007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31
N018916-008	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31
N018916-009	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31
N018916-010	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23
N018916-011	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018916-010	AP
N018916-011	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 12 · 473 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
2026-09-14 22:38:34	2026-08	N018916-001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	1,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-008	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-009	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-010	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018916-011	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018916-001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	1,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-008	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-009	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-010	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018916-011	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018916-001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	1,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-008	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-009	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-010	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018916-011	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200 UNITS/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1989-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-001	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%	1,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-002	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-003	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	5,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-004	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%	100 UNITS/ML	INJECTABLE / INJECTION			1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-005	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%	10,000 UNITS/100ML	INJECTABLE / INJECTION			1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-006	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018916-007	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		RLD, RS	1984-01-31	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N018916-010	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018916-011	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018916-010	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018916-011	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018916-010	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018916-011	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	0413f511-6b34-4c15-e48b-3fad08baacbe	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018916 application number: NDA018916 ndc (product): 0409-7650 ndc (product): 0409-7651 ndc (product): 0409-3150
Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	32e34077-aff1-4ec7-f9b0-b8e240768fb8	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018916 application number: NDA018916 ndc (product): 0409-7620
HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	51197aa6-de34-3a55-e063-6294a90a89c9	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018916 application number: NDA018916

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-3150	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7620	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7620	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7620	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7620	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7620	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7650	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7650	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7650	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7650	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7650	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7651	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7651	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7651	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7651	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7651	Heparin Sodium	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
51662-1411	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1411	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84321	SUPPL	2025-11-26
84241	SUPPL	2025-11-21
80563	SUPPL	2024-12-13
80552	SUPPL	2024-12-11
80009	SUPPL	2024-10-28
79995	SUPPL	2024-10-25
64167	SUPPL	2020-08-03
64151	SUPPL	2020-07-31
59917	SUPPL	2019-09-05
59910	SUPPL	2019-09-05
33644	SUPPL	2016-04-12
33643	SUPPL	2016-04-12
16090	SUPPL	2016-04-07
1126	SUPPL	2016-04-07
33642	SUPPL	2013-02-14
1125	SUPPL	2013-02-13
16089	SUPPL	2011-12-29
11359	SUPPL	2011-12-23