Furosemide

Product NDC: 68094-867
Requested package NDC: 68094-867-62
11-digit product format: 680940867
Labeler code: 68094
Product ID: 68094-867_1fbbdc90-7827-439a-8502-6f7a41a7c936
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose Inc.
Application: ANDA070433
Marketing category: ANDA
Marketing start: 2016-01-28
Substance: FUROSEMIDE
Active strength: 40 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070433-001	FUROSEMIDE	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-04-22

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL	RS	1987-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL	RS	1987-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL	RS	1987-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070433-001	FUROSEMIDE	40MG/5ML	SOLUTION / ORAL		1987-04-22	`f41ea6bd6efb…`

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/5mL

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
197731	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
3fd02fb5-98a0-4eda-a0ec-41faabe04706	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
68094-867-59	Furosemide	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	6
68094-867-62	Furosemide	10 in 1 TRAY	SOLUTION	10	6
68094-867-62	Furosemide	3 in 1 CASE	SOLUTION	3	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-867-59	ML - Milliliter	68094-867	bbe87e27-de8a-4da0-8a0d-071d87b1a01b	1	2016-04-04
68094-867-62	ML - Milliliter	68094-867	449dfbcd-7178-4a6b-9033-28d8157b7bc2	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-867	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240707_3fd02fb5-98a0-4eda-a0ec-41faabe04706.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Atlantic Biologicals Corps	9c342198-7162-4cc5-bda1-bc4054a4292b	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433
Furosemide	FUROSEMIDE	Precision Dose Inc.	3fd02fb5-98a0-4eda-a0ec-41faabe04706	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070433 application number: ANDA070433 ndc (package): 68094-867-62 ndc (product): 68094-867 ndc11 (package): 68094086762

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
197731	furosemide 40 MG in 5 mL Oral Solution	PSN	3fd02fb5-98a0-4eda-a0ec-41faabe04706	6
197731	furosemide 8 MG/ML Oral Solution	SCD	3fd02fb5-98a0-4eda-a0ec-41faabe04706	6
197731	furosemide 40 MG per 5 ML Oral Solution	SY	3fd02fb5-98a0-4eda-a0ec-41faabe04706	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-867-62	68094086762	3 TRAY in 1 CASE (68094-867-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-867-59)	3 tray	2016-01-28	0000-00-00	No	No	Current