Furosemide

Product NDC: 0054-3294
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

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 Identifiers#

Field, Values table
Field	Values
Unii	7LXU5N7ZO5
Rxcui	197730, 197731, 197732, 310429, 313988

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0054-3294-46	2022-08-05	C162847	48780-1	e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-08-05	C162847	48780-1	e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-46	2022-07-29	C162847	48780-1	e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e	Furosemide Tablets, USP and Furosemide Oral Solution, USP Rx only
0054-3294-50	2022-07-29	C162847	48780-1	e4f33bdf-a7a2-d8a0-e053-dadaa90a6e4e	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

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
0054-3294-46	00054329446	60 mL in 1 BOTTLE (0054-3294-46)	60 ml	1988-07-12	0000-00-00	No	No	Current
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 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

Furosemide

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#