Furosemide

Product NDC: 63187-097
11-digit product format: 631870097
Labeler code: 63187
Product ID: 63187-097_fed449e4-9657-4ca1-a8bc-7e14535d854b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078010
Marketing category: ANDA
Marketing start: 2009-01-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-097		D	Discontinued by firm		2026-08-10
excluded package	package	63187-097	63187-097-30	D	Discontinued by firm		2026-08-10

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-097-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-097-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-097-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078010-001	AB	1	`8072bd15b7f6…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FUROSEMIDE	ACTIVE INGREDIENT	7LXU5N7ZO5	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
FUROSEMIDE	ACTIVE MOIETY	7LXU5N7ZO5	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FUROSEMIDE TABLET [PROFICIENT RX LP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FUROSEMIDE TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-097	FUROSEMIDE TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191212_fa22943c-27d3-4419-be9b-ffe7de1a2416.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

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
63187-097-30	63187009730	30 TABLET in 1 BLISTER PACK (63187-097-30)	30 tablet	2014-07-01	0000-00-00	No	No	Current