Furosemide

Product NDC: 0054-3294
Requested package NDC: 0054-3294-50
11-digit product format: 000543294
Labeler code: 0054
Product ID: 0054-3294_bc62ddda-7639-4090-99f0-7dd4d13518f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Furosemide
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA070434
Marketing category: ANDA
Marketing start: 1988-07-12
Substance: FUROSEMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A070434-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	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 · 44 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
2026-10-15 13:18:30	2026-09	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL	AA	RS	1987-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070434-001	FUROSEMIDE	10MG/ML	SOLUTION / ORAL		RS	1987-04-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A070434-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070434-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070434-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070434-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070434-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070434-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070434-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070434-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070434-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070434-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070434-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070434-001	AA	1	`ea99ee380514…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FUROSEMIDE	10 mg/mL

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197730	Internal RxNorm lookup
197731	Internal RxNorm lookup
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
9e493331-dddd-496e-abf8-61747fb67aba	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0054-3294-46	2022-08-05	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-46	2022-08-05	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-08-05	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-08-05	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-46	2022-07-29	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-46	2022-07-29	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-07-29	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-07-29	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0054-3294-46	Furosemide	60 mL in 1 BOTTLE	SOLUTION	60	18
0054-3294-50	Furosemide	120 mL in 1 BOTTLE	SOLUTION	120	18
0054-3294-46	Furosemide	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60	1
0054-3294-50	Furosemide	120 mL in 1 BOTTLE, DROPPER	SOLUTION	120	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3294-46	ML - Milliliter	0054-3294	5378252d-1e74-4c17-9381-0a014930a27e	1	2012-07-24
0054-3294-50	ML - Milliliter	0054-3294	d9acaccb-17a9-45b3-9add-41b1a0ab5595	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FUROSEMIDE	ACTIVE INGREDIENT	7LXU5N7ZO5	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
FUROSEMIDE	ACTIVE MOIETY	7LXU5N7ZO5	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
POTASSIUM CARBONATE	INACTIVE INGREDIENT	BQN1B9B9HA	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
SORBITOL	INACTIVE INGREDIENT	506T60A25R	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
WATER O-15	INACTIVE INGREDIENT	63M8RYN44N	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [ROXANE LABORATORIES, INC]	7
FUROSEMIDE	ACTIVE INGREDIENT	7LXU5N7ZO5	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Furosemide	ACTIVE INGREDIENT	7LXU5N7ZO5	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
Furosemide	ACTIVE MOIETY	7LXU5N7ZO5	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
FUROSEMIDE	ACTIVE MOIETY	7LXU5N7ZO5	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
colloidal silicon dioxide	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
corn starch	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
D&C Yellow No. 10	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
lactose monohydrate	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
microcrystalline cellulose	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
orange flavoring	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
pineapple-peach flavoring	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Potassium Carbonate	INACTIVE INGREDIENT	BQN1B9B9HA	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
potassium carbonate 1 1/2 hydrate	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
pregelatinized starch	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
saccharin sodium	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Saccharin sodium anhydrous	INACTIVE INGREDIENT	I4807BK602	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
sodium starch glycolate	INACTIVE INGREDIENT		FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FUROSEMIDE SOLUTION [PRECISION DOSE INC.]	1
WATER, O-15	INACTIVE INGREDIENT	63M8RYN44N	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-3294	FUROSEMIDE TABLET FUROSEMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 2 package rows	20250511_9e493331-dddd-496e-abf8-61747fb67aba.zip
0054-3294	FUROSEMIDE (FUROSEMIDE) TABLET FUROSEMIDE (FUROSEMIDE) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20070509_EA623E21-E9FD-4EF1-843B-82CBC05AF5BF.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 Corp.	54ed0dd9-2fa8-269a-e063-6294a90a607c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434 ndc (package): 0054-3294-50 ndc (product): 0054-3294 ndc11 (package): 00054329450
Furosemide	FUROSEMIDE	Precision Dose Inc.	4a746634-379b-4847-a965-7607d2a71bed	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070434 application number: ANDA070434

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
197730	furosemide 10 MG in 1 mL Oral Solution	PSN	9e493331-dddd-496e-abf8-61747fb67aba	18
310429	furosemide 20 MG Oral Tablet	PSN	9e493331-dddd-496e-abf8-61747fb67aba	18
197731	furosemide 40 MG in 5 mL Oral Solution	PSN	9e493331-dddd-496e-abf8-61747fb67aba	18
313988	furosemide 40 MG Oral Tablet	PSN	9e493331-dddd-496e-abf8-61747fb67aba	18
197732	furosemide 80 MG Oral Tablet	PSN	9e493331-dddd-496e-abf8-61747fb67aba	18
197730	furosemide 10 MG/ML Oral Solution	SCD	9e493331-dddd-496e-abf8-61747fb67aba	18
310429	furosemide 20 MG Oral Tablet	SCD	9e493331-dddd-496e-abf8-61747fb67aba	18
313988	furosemide 40 MG Oral Tablet	SCD	9e493331-dddd-496e-abf8-61747fb67aba	18
197731	furosemide 8 MG/ML Oral Solution	SCD	9e493331-dddd-496e-abf8-61747fb67aba	18
197732	furosemide 80 MG Oral Tablet	SCD	9e493331-dddd-496e-abf8-61747fb67aba	18
197730	furosemide 1 % Oral Solution	SY	9e493331-dddd-496e-abf8-61747fb67aba	18
197730	furosemide 10 MG per 1 ML Oral Solution	SY	9e493331-dddd-496e-abf8-61747fb67aba	18
197730	furosemide 40 MG per 4 ML Oral Solution	SY	9e493331-dddd-496e-abf8-61747fb67aba	18
197731	furosemide 40 MG per 5 ML Oral Solution	SY	9e493331-dddd-496e-abf8-61747fb67aba	18
197730	furosemide 10 MG in 1 mL Oral Solution	PSN	4a746634-379b-4847-a965-7607d2a71bed	7
197730	furosemide 10 MG/ML Oral Solution	SCD	4a746634-379b-4847-a965-7607d2a71bed	7
197730	furosemide 1 % Oral Solution	SY	4a746634-379b-4847-a965-7607d2a71bed	7
197730	furosemide 10 MG per 1 ML Oral Solution	SY	4a746634-379b-4847-a965-7607d2a71bed	7
197730	furosemide 40 MG per 4 ML Oral Solution	SY	4a746634-379b-4847-a965-7607d2a71bed	7
197730	furosemide 10 MG in 1 mL Oral Solution	PSN	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
310429	furosemide 20 MG Oral Tablet	PSN	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197731	furosemide 40 MG in 5 mL Oral Solution	PSN	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
313988	furosemide 40 MG Oral Tablet	PSN	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197732	furosemide 80 MG Oral Tablet	PSN	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197730	furosemide 10 MG/ML Oral Solution	SCD	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
310429	furosemide 20 MG Oral Tablet	SCD	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
313988	furosemide 40 MG Oral Tablet	SCD	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197731	furosemide 8 MG/ML Oral Solution	SCD	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197732	furosemide 80 MG Oral Tablet	SCD	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197730	furosemide 1 % Oral Solution	SY	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197730	furosemide 10 MG per 1 ML Oral Solution	SY	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197730	furosemide 40 MG per 4 ML Oral Solution	SY	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1
197731	furosemide 40 MG per 5 ML Oral Solution	SY	ea623e21-e9fd-4ef1-843b-82cbc05af5bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3294-50	00054329450	120 mL in 1 BOTTLE (0054-3294-50)	120 ml	1988-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furosemide Oral Solution, USP Rx only	Atlantic Biologicals Corp.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	1
Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	18
Furosemide Oral Solution USP	Precision Dose Inc.	2022-09-21	HUMAN PRESCRIPTION DRUG LABEL	7
Furosemide		2007-03-31	Human prescription drug label	1