Furosemide

Product NDC: 43353-018
Requested package NDC: 43353-018-80
11-digit product format: 433530018
Labeler code: 43353
Product ID: 43353-018_6b8291f1-dcbd-4c61-92a4-9b1d35eeecdc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077293
Marketing category: ANDA
Marketing start: 2006-02-01
Marketing end: 0000-00-00
Substance: FUROSEMIDE
Active strength: 40 mg/1
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-018	43353-018-80	D	Discontinued by firm		2026-08-17

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077293-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09
A077293-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09
A077293-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077293-001	AB
A077293-002	AB
A077293-003	AB

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 4 · 126 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	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077293-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2005-11-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077293-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077293-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077293-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077293-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077293-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077293-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077293-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077293-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077293-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077293-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077293-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077293-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077293-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077293-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077293-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077293-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077293-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077293-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077293-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077293-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077293-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077293-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-018-30	EA - Each	43353-018	d0b4eb9d-f4cb-4785-8766-7c171acbd279	1	2016-07-19
43353-018-45	EA - Each	43353-018	e322779d-4cd7-420d-ae46-a5d025a26b3f	1	2016-07-19
43353-018-53	EA - Each	43353-018	bba69ed4-2dc4-480d-bc30-8d6c1dcdb86c	1	2016-07-19
43353-018-60	EA - Each	43353-018	d3f64bd8-e74b-43c0-8332-96159eb0cd7f	1	2016-07-19
43353-018-80	EA - Each	43353-018	ae687328-53f8-441e-8bbc-3ccd6b07ccfa	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-018	FUROSEMIDE (FUROSEMIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20160708_f7aec34c-2373-483c-b89c-2c53320f3829.zip

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	7cdcd001-ab4b-4210-a455-2e17a7bc4972	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	916de29e-228c-4dfc-bcee-ad9a641316bd	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	571a52ed-5258-46d5-a0d2-9a984cf73895	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Unit Dose Solutions, Inc.	54dd664a-c7ec-27f3-e063-6294a90aff9f	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Coupler LLC	53e58232-f7f9-c09b-e063-6394a90a5bc4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals, Inc.	a23fc1e0-2d16-43a8-a34e-f6505dcd6316	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals Inc.	cad102d7-0197-4cff-bb80-9f0b5bcb599b	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Direct_Rx	e9be5c3b-4b18-7ad2-e053-2995a90a4a8b	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
FUROSEMIDE	FUROSEMIDE	Northwind Health Company, LLC	1d99e151-75ba-6a75-e063-6294a90a4360	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	QPharma Inc	341e29d9-a6f1-4c77-ae44-9b2c423ea6b4	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	7842eeab-decf-47e7-9134-0add90549a3d	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	e20257f6-7cfe-43fa-a672-cc1cb312b83a	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	3f6529fb-1173-ada3-e063-6294a90a76cb	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Proficient Rx LP	600ca175-be2b-4c43-b119-133ae21a5601	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Coupler LLC	33ec71e2-8fbd-0703-e063-6294a90a62e1	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	809d9734-12dd-3b1f-e053-2a91aa0aadee	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	813c8e9b-61bc-27c4-e053-2a91aa0a9f45	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	0dd28e18-2e15-45eb-9a61-a9de7bd7d64e	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	809b4f68-4fca-c201-e053-2a91aa0ac18e	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	307c3b89-f37f-45ee-8ec7-d402008cf2fa	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077293 application number: ANDA077293

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	Marketing end	Sample	Exclude flag	Status
43353-018-80	43353001880	180 TABLET in 1 BOTTLE (43353-018-80)	180 tablet	2015-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furosemide Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2016-06-13	HUMAN PRESCRIPTION DRUG LABEL	1