Application 019339

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No
002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	No	No
003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	No	No
004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27
N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27
N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27
N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	HEPARIN SODIUM	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019339-002	AP
N019339-003	AP
N019339-004	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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019339-001	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION		1985-03-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019339-002	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019339-003	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	10,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019339-004	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	5,000 UNITS/100ML	INJECTABLE / INJECTION	AP	1985-03-27	`ea99ee380514…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N019339-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019339-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019339-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019339-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019339-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019339-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019339-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019339-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019339-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019339-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019339-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019339-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019339-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019339-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019339-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019339-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019339-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019339-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019339-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019339-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019339-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019339-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019339-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019339-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019339-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019339-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019339-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019339-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019339-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019339-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019339-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019339-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019339-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019339-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019339-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019339-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019339-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019339-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019339-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019339-002	AP	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	eede8a0c-5ae6-4166-84b3-12081405f08e	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019339 application number: NDA019339 ndc (product): 0409-4520 ndc (product): 0409-7793

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4520	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7793	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7793	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7793	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7793	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current
0409-7793	Heparin Sodium and Dextrose	HEPARIN SODIUM	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77424	SUPPL	2024-02-08
77419	SUPPL	2024-02-07
59918	SUPPL	2019-09-05
59911	SUPPL	2019-09-05
57002	SUPPL	2018-12-21
56964	SUPPL	2018-12-21
11478	SUPPL	2014-03-19
17361	SUPPL	2014-03-18
17360	SUPPL	2011-12-29
33726	SUPPL	2011-12-23
17359	SUPPL	2009-07-31
1288	SUPPL	2008-10-21