NDC Code(s) : 55154-4915-5, 55154-4906-0, 55154-4908-0, 55154-4909-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FurosemideFurosemide SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4915(NDC:0054-8298)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE(UNII: 7LXU5N7ZO5)
(FUROSEMIDE - UNII:7LXU5N7ZO5) 		FUROSEMIDE40 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
POTASSIUM CARBONATE(UNII: BQN1B9B9HA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SORBITOL(UNII: 506T60A25R)
WATER O-15(UNII: 63M8RYN44N)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4915-55 in 1 BAG 22/04/1987
15 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070433 04/22/1987 06/30/2016
FurosemideFurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4906(NDC:0054-4297)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 54;840
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4906-010 in 1 BAG 11/10/1983
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018823 11/10/1983 04/30/2010
FurosemideFurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4908(NDC:0054-8299)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code 54;583
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4908-010 in 1 BAG 11/10/1983
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018823 11/10/1983
FurosemideFurosemide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4909(NDC:0054-8301)
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code 54;533
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4909-010 in 1 BAG 24/01/1986
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070086 01/24/1986

PRINCIPAL DISPLAY PANEL

Furosemide Tablets USP

20 mg

10 Tablets

bag label

PRINCIPAL DISPLAY PANEL

Furosemide Tablets USP

40 mg

10 Tablets

bag label

PRINCIPAL DISPLAY PANEL

Furosemide Tablets USP

80 mg

10 Tablets

bag label

PRINCIPAL DISPLAY PANEL

Furosemide Oral Solution USP

40 mg per 5 mL

5 Unit Dose Cups

bag label