WARNINGS

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs. (See DOSAGE AND ADMINISTRATION.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73542-101-01
Furosemide Injection, USP
20 mg/2 mL
(10 mglmL)
FOR IV OR IM USE
Rx only
2 mL Single-Dose vial

vial-label-2ml

NDC 73542-101-25
Furosemide Injection, USP
20 mg/2 mL
(10 mglmL)
FOR IV OR IM USE
Rx only
25 Single-Dose vial

carton-label-2ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73542-102-02
Furosemide Injection, USP
40 mg/4 mL
(10 mglmL)
FOR IV OR IM USE
Rx only
4 mL Single-Dose vial

vial-label-4ml

NDC 73542-102-25
Furosemide Injection, USP
40 mg/4 mL
(10 mglmL)
FOR IV OR IM USE
Rx only
25 Single-Dose via

carton-label-4ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73542-103-03
Furosemide Injection, USP
100 mg/10 mL
(10 mglmL)
FOR IV OR IM USE
Rx only
10 mL Single-Dose vial

vial-label-10ml

NDC 73542-103-25
Furosemide Injection, USP
100 mg/10 mL
(10 mglmL)
FOR IV OR IM USE
Rx only

25 Single-Dose vial

carton-label-10ml

FUROSEMIDE
furosemide injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:73542-101
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73542-101-25	25 in 1 CARTON	06/16/2025
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203428	06/16/2025

FUROSEMIDE
furosemide injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:73542-102
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73542-102-25	25 in 1 CARTON	06/16/2025
1		4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203428	06/16/2025

FUROSEMIDE
furosemide injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:73542-103
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73542-103-25	25 in 1 CARTON	06/16/2025
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203428	06/16/2025

Labeler - Maiva Pharma Private Limited (725656438)

Registrant - Maiva Pharma Private Limited (725656438)

Name	Address	ID/FEI	Business Operations
Establishment
Maiva Pharma Private Limited		725656438	analysis(73542-101, 73542-102, 73542-103) , manufacture(73542-101, 73542-102, 73542-103) , pack(73542-101, 73542-102, 73542-103) , label(73542-101, 73542-102, 73542-103)