Furosemide

Product NDC: 70518-4679
Requested package NDC: 70518-4679-0
11-digit product format: 705184679
Labeler code: 70518
Product ID: 70518-4679_54eaffef-1bd9-a3ec-e063-6294a90af14b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078010
Marketing category: ANDA
Marketing start: 2026-06-22
Substance: FUROSEMIDE
Active strength: 20 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078010-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18
A078010-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18
A078010-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078010-001	AB
A078010-002	AB
A078010-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078010-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078010-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078010-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078010-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078010-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078010-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-001	AB	1	`301d65b070ca…`

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	20 mg/1

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
310429	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
e8c27f1c-dc81-44b1-8663-a7d663bad89f	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	e8c27f1c-dc81-44b1-8663-a7d663bad89f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010 ndc (package): 70518-4679-0 ndc (product): 70518-4679 ndc11 (package): 70518467900
Furosemide	FUROSEMIDE	Coupler LLC	4cc2c2d1-2fa4-f6b6-e063-6294a90a290e	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	ac64c926-88e9-453a-884c-72ec6a1c746a	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	3f3248cd-d62f-49ca-8788-f059e8facd91	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	c81d313c-65a3-4fb5-b6cd-b1c1ec7dca03	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	5d7eb469-2371-4abb-8f49-be1596f10f27	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	85375079-a9f1-42d4-8e15-c1d31395b29d	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	Coupler LLC	3eed4bbf-7d0e-e852-e063-6394a90a85c2	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	Ipca Laboratories Limited	0acd293b-ecab-4879-a8e7-cd1b76148f2a	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010

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
70518-4679-0	70518467900	30 TABLET in 1 BLISTER PACK (70518-4679-0)	30 tablet	2026-06-22	No	No	Current