Losortan Potassium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25mg
(click image for full-size original)

50mg
(click image for full-size original)
100mg
(click image for full-size original)
LOSORTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-504(NDC:68382-135)
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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 8mm
Flavor Imprint Code Z;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-504-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-504-11)
1 NDC:50268-504-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (50268-504-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 05/29/2020
LOSORTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-505(NDC:68382-136)
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
SILICON DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code Z16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-505-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-505-11)
1 NDC:50268-505-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (50268-505-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 05/29/2020
LOSORTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-506(NDC:68382-137)
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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 12mm
Flavor Imprint Code Z18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-506-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-506-11)
1 NDC:50268-506-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (50268-506-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 05/29/2020
Labeler — AvPAK (832926666)

Revised: 01/2024 AvPAK

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