Furosemide

Product NDC: 71335-2319
Requested package NDC: 71335-2319-9
11-digit product format: 713352319
Labeler code: 71335
Product ID: 71335-2319_bf3ea890-deb2-4839-9cfe-062f8afec109
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216629
Marketing category: ANDA
Marketing start: 2022-11-05
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	RLD / RS	Approval date
A216629-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17
A216629-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17
A216629-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216629-001	AB
A216629-002	AB
A216629-003	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 3 · 81 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
2026-09-14 22:38:34	2026-08	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	RS	2022-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-002	FUROSEMIDE	40MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-003	FUROSEMIDE	80MG	TABLET / ORAL	AB		2022-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-001	FUROSEMIDE	20MG	TABLET / ORAL	AB		2022-10-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 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	A216629-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216629-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216629-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216629-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216629-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216629-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216629-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216629-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216629-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216629-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216629-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216629-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216629-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216629-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216629-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216629-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216629-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216629-001	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 · 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
53c3f50f-57c6-441b-afea-ec43d7943d1a	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
71335-2319-0	Furosemide	6 in 1 BOTTLE	TABLET	6	101
71335-2319-1	Furosemide	30 in 1 BOTTLE	TABLET	30	101
71335-2319-2	Furosemide	90 in 1 BOTTLE	TABLET	90	101
71335-2319-3	Furosemide	60 in 1 BOTTLE	TABLET	60	101
71335-2319-4	Furosemide	100 in 1 BOTTLE	TABLET	100	101
71335-2319-5	Furosemide	7 in 1 BOTTLE	TABLET	7	101
71335-2319-6	Furosemide	28 in 1 BOTTLE	TABLET	28	101
71335-2319-7	Furosemide	14 in 1 BOTTLE	TABLET	14	101
71335-2319-8	Furosemide	10 in 1 BOTTLE	TABLET	10	101
71335-2319-9	Furosemide	20 in 1 BOTTLE	TABLET	20	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2319	FUROSEMIDE TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 10 package rows	20240105_53c3f50f-57c6-441b-afea-ec43d7943d1a.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	dba00759-87b4-4ecf-998e-ba03ed3d2f1a	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Redpharm Drug	58d2a38d-75f8-dcb9-e063-6294a90a10d7	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	St. Mary's Medical Park Pharmacy	febeaf8c-0f4b-cc40-e053-6394a90a873e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Redpharm Drug	37457273-38a1-f938-e063-6294a90a50ab	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals Inc.	adda78ee-0cf5-4613-a748-5d6571afe354	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	8f56d6f6-a5ea-4171-9e24-d2fdb11a65f8	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	13ba97a7-598a-76a4-e063-6294a90a45c5	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Redpharm Drug	3745be12-ea1d-f450-e063-6294a90a148c	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	54a33042-a163-4f93-96cc-fbd93030e014	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	6864b3f6-c5ad-4588-ad04-5260258c6d8c	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals, Inc.	20eecc36-dfb7-0060-e063-6394a90a9d0b	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	A-S Medication Solutions	6194face-c26c-46ed-bde7-1e29bfeabd88	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	53c3f50f-57c6-441b-afea-ec43d7943d1a	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629 ndc (package): 71335-2319-9 ndc (product): 71335-2319 ndc11 (package): 71335231909
Furosemide	FUROSEMIDE	Prefferred Pharmaceuticals Inc.	ede9846b-b4c5-4be2-9188-fd65e66cd893	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Rising Pharma Holdings, Inc.	6101b9b4-f3ef-438e-a857-b4ea55ffc679	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	6c2ee3a4-afea-4e1f-84e6-def0221ad437	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216629 application number: ANDA216629

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	53c3f50f-57c6-441b-afea-ec43d7943d1a	101
310429	furosemide 20 MG Oral Tablet	SCD	53c3f50f-57c6-441b-afea-ec43d7943d1a	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2319-9	71335231909	20 TABLET in 1 BOTTLE (71335-2319-9)	20 tablet	2024-01-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furosemide Tablets, USP 20 mg, 40 mg, and 80 mg Rx Only	Bryant Ranch Prepack	2025-09-29	HUMAN PRESCRIPTION DRUG LABEL	101