Losartan Potassium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 25 mg

Losartan Potassium Tablets USP 25 mg (30 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP…… 25 mg
46708-445-30

30 Tablets in HDPE bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 50 mg

Losartan Potassium Tablets USP 50 mg (30 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP…… 50 mg 46708-446-30

30 Tablets in HDPE bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 100 mg

Losartan Potassium Tablets USP 100 mg (30 Tablets in HDPE bottle)
Each film coated tablet contains: Losartan Potassium USP….. 100 mg 46708-447-30

30 Tablets in HDPE bottle
(click image for full-size original)
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-445
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score no score
Shape ROUND (Circular, biconvex) Size 6mm
Flavor Imprint Code L143
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-445-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-445-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-445-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-445-31 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 05/23/2016
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-446
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND (Circular, biconvex) Size 8mm
Flavor Imprint Code L142
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-446-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-446-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-446-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-446-31 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 05/23/2016
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-447
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN Score no score
Shape ROUND (Circular, biconvex) Size 11mm
Flavor Imprint Code L126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-447-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-447-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:46708-447-91 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:46708-447-31 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090428 05/23/2016
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-445), MANUFACTURE (46708-446), MANUFACTURE (46708-447)

Revised: 11/2019 Alembic Pharmaceuticals Limited

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