Losartan Potassium (Page 8 of 8)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Losartan Potassium Tablets USP, 25 mg 90 Tablets

0054-0123-22, Rx only

bl-25mg-90s
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Losartan Potassium Tablets USP, 50 mg 90 Tablets

0054-0124-22, Rx only

bl-50mg-90s-c50000724-01-k02
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Losartan Potassium Tablets USP, 100 mg 90 Tablets

0054-0125-22, Rx only

bl-100mg-90s-c50000725-01-k02
(click image for full-size original)
LOSARTAN POTASSIUM
losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0123
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 54;277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0123-22 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077459 07/13/2020
LOSARTAN POTASSIUM
losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0124
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 54;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0124-22 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077459 07/13/2020
LOSARTAN POTASSIUM
losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0125
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 54;357
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0125-22 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077459 07/13/2020
Labeler — Hikma Pharmaceuticals USA Inc. (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0123), MANUFACTURE (0054-0124), MANUFACTURE (0054-0125)

Revised: 10/2021 Hikma Pharmaceuticals USA Inc.

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