Furosemide

Product NDC: 48433-314
11-digit product format: 484330314
Labeler code: 48433
Product ID: 48433-314_d7e7508a-6f54-4349-9bd4-238fa48b3ae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: NDA018569
Marketing category: NDA
Marketing start: 2014-09-30
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: 2019-12-31
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	48433-314		D	Discontinued by firm		2026-08-07
excluded package	package	48433-314	48433-314-10	D	Discontinued by firm		2026-08-07

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48433-314-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48433-314-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48433-314-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48433-314-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48433-314-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	48433-314-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	48433-314-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	48433-314-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	48433-314-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	48433-314-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	48433-314-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	48433-314-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N018569-001	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982
N018569-002	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982
N018569-005	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018569-001	AB
N018569-002	AB
N018569-005	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`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	N018569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018569-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018569-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018569-001	AB	1	`8072bd15b7f6…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FUROSEMIDE	ACTIVE INGREDIENT	7LXU5N7ZO5	FUROSEMIDE TABLET [SAFECOR HEALTH, LLC]	1
FUROSEMIDE	ACTIVE MOIETY	7LXU5N7ZO5	FUROSEMIDE TABLET [SAFECOR HEALTH, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FUROSEMIDE TABLET [SAFECOR HEALTH, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FUROSEMIDE TABLET [SAFECOR HEALTH, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FUROSEMIDE TABLET [SAFECOR HEALTH, LLC]	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Granulation Technology, Inc.	462e8917-cbe0-f4f9-e063-6394a90ab4ff	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018569 application number: NDA018569
Furosemide	FUROSEMIDE	Marlex Pharmaceuticals, Inc.	4bd1b15e-354e-051f-e063-6294a90a3f3b	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018569 application number: NDA018569