Application 018667

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	INJECTABLE;INJECTION	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018667-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP		1982-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018667-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018667-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1982-05-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018667-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018667-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018667-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018667-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018667-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018667-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018667-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018667-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018667-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018667-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018667-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018667-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018667-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018667-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018667-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018667-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018667-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018667-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018667-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018667-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018667-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018667-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018667-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018667-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018667-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018667-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018667-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018667-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018667-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018667-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018667-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018667-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018667-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018667-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018667-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018667-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018667-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018667-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018667-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018667-001	AP	1	`e64feba35796…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	58cc1e38-6000-1489-e063-6394a90a5978	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	75d5611a-f9e0-1841-e053-2991aa0af415	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 51662-1226
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	71b48f4d-9936-448c-9e3a-33f1182e1039	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 55154-2365
Furosemide	FUROSEMIDE	Hospira, Inc.	39fd32f2-6bb7-4a65-d298-e48d26bc80c7	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 0409-6102
FUROSEMIDE	FUROSEMIDE	Hospira, Inc.	aaced7a8-c3d7-4d66-8c07-aa407b8b3f35	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 0409-6102
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	8e0bac29-5a8b-4d4e-93b3-2e21eb3b0650	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 55154-2364
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	75d68f19-424c-109e-e053-2991aa0ac857	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 51662-1227
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	7b9af6a4-e1da-eb95-e053-2991aa0a031d	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018667 application number: NDA018667 ndc (product): 51662-1336

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	FUROSEMIDE	furosemide	Hospira, Inc.	NDA	Current
0409-6102	FUROSEMIDE	furosemide	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	FUROSEMIDE	furosemide	Hospira, Inc.	NDA	Current
0409-6102	FUROSEMIDE	furosemide	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	Furosemide	FUROSEMIDE	Hospira, Inc.	NDA	Current
0409-6102	FUROSEMIDE	furosemide	Hospira, Inc.	NDA	Current
51662-1226	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1226	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1226	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1226	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1226	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1227	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1336	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1336	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1336	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1336	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-102	Furosemide	Furosemide	General Injectables & Vaccines, Inc	NDA	Current
52584-102	Furosemide	Furosemide	General Injectables & Vaccines, Inc	NDA	Current
52584-102	Furosemide	Furosemide	General Injectables & Vaccines, Inc	NDA	Current
55154-2364	Furosemide	Furosemide	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-2364	Furosemide	Furosemide	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-2364	Furosemide	Furosemide	Cardinal Health 107, LLC	NDA AUTHORIZED GENERIC	Current
55154-2364	Furosemide	Furosemide	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-2365	Furosemide	FUROSEMIDE	Cardinal Health	NDA	Current
55154-2365	Furosemide	Furosemide	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-2365	Furosemide	FUROSEMIDE	Cardinal Health	NDA	Current
55154-2365	Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	NDA	Current
55154-2365	Furosemide	FUROSEMIDE	Cardinal Health	NDA	Current
55154-2391	Furosemide	Furosemide	Cardinal Health	NDA AUTHORIZED	Current
55154-7830	FUROSEMIDE	furosemide	Cardinal Health	NDA	Current
55154-7830	FUROSEMIDE	furosemide	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79814	SUPPL	2024-10-03
79807	SUPPL	2024-10-03
73727	SUPPL	2023-03-10
71991	SUPPL	2022-09-01
71989	SUPPL	2022-09-01
45530	SUPPL	2016-10-12
45413	SUPPL	2016-09-29