NDC Code(s) : 0517-5702-25, 0517-5704-25, 0517-5710-25
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FurosemideFurosemide INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-5702
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-5702-2525 in 1 TRAY
12 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018579 09/30/1990
FurosemideFurosemide INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-5704
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-5704-2525 in 1 TRAY
14 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018579 09/30/1990
FurosemideFurosemide INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-5710
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-5710-2525 in 1 TRAY
110 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018579 09/30/1990

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2 mL Container

NDC 0517-5702-25

FUROSEMIDE INJECTION, USP

20 mg/2 mL (10 mg/mL)

2 mL SINGLE DOSE VIAL

FOR IV OR IM USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

2 mL Container

PRINCIPAL DISPLAY PANEL – 2 mL Carton

FUROSEMIDE INJECTION, USP

20 mg/2 mL (10 mg/mL)

NDC 0517-5702-25

25 x 2 mL SINGLE DOSE VIALS

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx Only

Each mL contains: Furosemide 10 mg, Water for Injection q.s. Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.
WARNING: DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR AND COLORLESS. PROTECT FROM LIGHT.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

2 mL Container

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 4 mL Container

NDC 0517-5704-25

FUROSEMIDE INJECTION, USP

40 mg/4 mL (10 mg/mL)

4 mL SINGLE DOSE VIAL

FOR IV OR IM USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

4 mL Container

PRINCIPAL DISPLAY PANEL – 4 mL Carton

FUROSEMIDE INJECTION, USP

40 mg/4 mL (10 mg/mL)

NDC 0517-5704-25

25 x 4 mL SINGLE DOSE VIALS

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx Only

Each mL contains: Furosemide 10 mg, Water for Injection q.s. Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.
WARNING: DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR AND COLORLESS. PROTECT FROM LIGHT.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

4 mL Container

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mL Container

NDC 0517-5710-25

FUROSEMIDE INJECTION, USP

100 mg/10 mL (10 mg/mL)

10 mL SINGLE DOSE VIAL

FOR IV OR IM USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

10 mL Container

PRINCIPAL DISPLAY PANEL – 10 mL Carton

FUROSEMIDE INJECTION, USP

100 mg/10 mL (10 mg/mL)

NDC 0517-5710-25

25 x 10 mL SINGLE DOSE VIALS

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx Only

Each mL contains: Furosemide 10 mg, Water for Injection q.s. Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.
WARNING: DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR AND COLORLESS. PROTECT FROM LIGHT.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

10 mL Container