Furosemide

Product NDC: 83980-002
11-digit product format: 839800002
Labeler code: 83980
Product ID: 83980-002_2ef79eb1-61e5-4697-9292-336ca5cf5116
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: Ipca Laboratories Limited
Application: ANDA078010
Marketing category: ANDA
Marketing start: 2024-06-03
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: 2026-12-31
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: 2026-12-31

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 · 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
0acd293b-ecab-4879-a8e7-cd1b76148f2a	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	SPL version
83980-002-01	Furosemide	100 in 1 BOTTLE	TABLET	100	3
83980-002-10	Furosemide	1000 in 1 BOTTLE	TABLET	1000	3
83980-002-97	Furosemide	10 in 1 BOTTLE	TABLET	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83980-002-01	EA - Each	83980-002	c27f7507-cc70-43aa-8398-ac74bdaa6f8a	1	2024-08-12
83980-002-10	EA - Each	83980-002	eeca1f79-8c79-4e35-9434-8b969865811e	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83980-002	FUROSEMIDE TABLET [IPCA LABORATORIES LIMITED]	3	Current NDC, 3 package rows	20250121_0acd293b-ecab-4879-a8e7-cd1b76148f2a.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 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
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 ndc (product): 83980-002

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	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
313988	furosemide 40 MG Oral Tablet	PSN	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
197732	furosemide 80 MG Oral Tablet	PSN	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
310429	furosemide 20 MG Oral Tablet	SCD	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
313988	furosemide 40 MG Oral Tablet	SCD	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
197732	furosemide 80 MG Oral Tablet	SCD	0acd293b-ecab-4879-a8e7-cd1b76148f2a	3
310429	furosemide 20 MG Oral Tablet	PSN	3eed4bbf-7d0e-e852-e063-6394a90a85c2	1
310429	furosemide 20 MG Oral Tablet	PSN	3f3248cd-d62f-49ca-8788-f059e8facd91	1
310429	furosemide 20 MG Oral Tablet	PSN	85375079-a9f1-42d4-8e15-c1d31395b29d	1
310429	furosemide 20 MG Oral Tablet	SCD	3eed4bbf-7d0e-e852-e063-6394a90a85c2	1
310429	furosemide 20 MG Oral Tablet	SCD	3f3248cd-d62f-49ca-8788-f059e8facd91	1
310429	furosemide 20 MG Oral Tablet	SCD	85375079-a9f1-42d4-8e15-c1d31395b29d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83980-002-01	83980000201	100 TABLET in 1 BOTTLE (83980-002-01)	100 tablet	2024-06-03	No	No	Current
83980-002-10	83980000210	1000 TABLET in 1 BOTTLE (83980-002-10)	1000 tablet	2024-06-03	No	No	Current
83980-002-97	83980000297	10 TABLET in 1 BOTTLE (83980-002-97)	10 tablet	2024-06-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FUROSEMIDE TABLETS, USP Rx only	REMEDYREPACK INC.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	1
FUROSEMIDE TABLETS, USP Rx only	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	1
FUROSEMIDE TABLETS, USP Rx only	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	1
FUROSEMIDE TABLETS, USP Rx only	Coupler LLC \| Ipca Laboratories Limited	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	1
FUROSEMIDE TABLETS, USP Rx only	Ipca Laboratories Limited \| Guardian Drug Company	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	3