FUROSEMIDE

Product NDC: 59651-797
Requested package NDC: 59651-797-72
11-digit product format: 596510797
Labeler code: 59651
Product ID: 59651-797_a504ee4b-3995-45f2-898c-91116dd81d19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FUROSEMIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA218831
Marketing category: ANDA
Marketing start: 2025-07-17
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: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	59651-797	59651-797-72	UNFINISHED	Active or certified unfinished drug listing		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	59651-797	59651-797-72	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	59651-797	59651-797-72	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`

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
A218831-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17
A218831-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17
A218831-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218831-001	AB
A218831-002	AB
A218831-003	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.

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	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2025-07-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2025-07-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2025-07-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218831-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218831-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218831-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218831-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218831-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218831-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218831-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218831-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218831-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218831-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218831-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218831-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218831-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218831-003	AB	1	`a50c72e98297…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FUROSEMIDE	40 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197732	Internal RxNorm lookup
310429	Internal RxNorm lookup
313988	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
a504ee4b-3995-45f2-898c-91116dd81d19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d80d3aff-3a63-4d7b-a2be-fd9388b04330	Product name	9	20250806
9061e89f-9c86-4196-b34b-886fc1673cc4	Product name	1	20140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-797-01	FUROSEMIDE	100 in 1 BOTTLE	TABLET	100		1
59651-797-99	FUROSEMIDE	1000 in 1 BOTTLE	TABLET	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-797-01	EA - Each	59651-797	5486025f-60cb-4975-866f-ba35ad1f2eb8	1	2025-09-12
59651-797-99	EA - Each	59651-797	8a28dcaa-12ef-42e5-a472-bb37577a511e	1	2025-09-12

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
FUROSEMIDE	FUROSEMIDE	Aurobindo Pharma Limited	a504ee4b-3995-45f2-898c-91116dd81d19	2025-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218831 application number: ANDA218831 ndc (product): 59651-797

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310429	furosemide 20 MG Oral Tablet	PSN	a504ee4b-3995-45f2-898c-91116dd81d19	1
313988	furosemide 40 MG Oral Tablet	PSN	a504ee4b-3995-45f2-898c-91116dd81d19	1
197732	furosemide 80 MG Oral Tablet	PSN	a504ee4b-3995-45f2-898c-91116dd81d19	1
310429	furosemide 20 MG Oral Tablet	SCD	a504ee4b-3995-45f2-898c-91116dd81d19	1
313988	furosemide 40 MG Oral Tablet	SCD	a504ee4b-3995-45f2-898c-91116dd81d19	1
197732	furosemide 80 MG Oral Tablet	SCD	a504ee4b-3995-45f2-898c-91116dd81d19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-797-72	59651079772	75000 TABLET in 1 BAG (59651-797-72)	75000 tablet	17-JUL-25	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furosemide Tablets USP, 20 mg, 40 mg and 80 mg Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-07-19	Human Prescription Drug Label	1