NDC Code(s) : 0603-3739-21, 0603-3739-32, 0603-3739-34, 0603-3740-21, 0603-3740-32, 0603-3740-34, 0603-3741-21, 0603-3741-28, 0603-3741-32
Packager : Qualitest Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Furosemidefurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3739
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (off-white) Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code 3169;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-3739-21100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
2NDC:0603-3739-321000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
3NDC:0603-3739-345000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076796 03/26/2004 09/30/2018
Furosemidefurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 3170;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-3740-21100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
2NDC:0603-3740-321000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
3NDC:0603-3740-345000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076796 03/26/2004 09/30/2018
Furosemidefurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3741
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code 3171;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-3741-21100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
2NDC:0603-3741-28500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
3NDC:0603-3741-321000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/03/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076796 03/26/2004 07/31/2018

PRINCIPAL DISPLAY PANEL

This is an image of the label for Furosemide 20 mg.

PRINCIPAL DISPLAY PANEL

This is an image of the label for Furosemide 40 mg.

PRINCIPAL DISPLAY PANEL

This is an image of the label for Furosemide 80 mg.