Furosemide

Product NDC: 17856-3294
11-digit product format: 178563294
Labeler code: 17856
Product ID: 17856-3294_54ed0de5-046f-06d7-e063-6394a90ad3b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corp.
Application: ANDA070434
Marketing category: ANDA
Marketing start: 1988-07-12
Substance: FUROSEMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A070434-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22

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 · 43 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	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A070434-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070434-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070434-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070434-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070434-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070434-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070434-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070434-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070434-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070434-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070434-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070434-001	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Furosemide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FUROSEMIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7LXU5N7ZO5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197730	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
54ed0dd9-2fa8-269a-e063-6294a90a607c	Available on FDA.report

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
Furosemide	FUROSEMIDE	Atlantic Biologicals Corp.	54ed0dd9-2fa8-269a-e063-6294a90a607c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434 ndc (product): 17856-3294
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434
Furosemide	FUROSEMIDE	Precision Dose Inc.	4a746634-379b-4847-a965-7607d2a71bed	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7LXU5N7ZO5	FUROSEMIDE	54-31-9	FUROSEMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
17856-3294-1	17856329401	120 SYRINGE in 1 CASE (17856-3294-1) / 3 mL in 1 SYRINGE	120 syringe	2026-06-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furosemide Oral Solution, USP Rx only	Atlantic Biologicals Corp.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	1