Losartan Potassium (Page 8 of 8)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 25 mg (90 Tablets Bottle)

Rising® NDC 57237-204-90
Losartan
Potassium
Tablets USP
25 mg

90 Tablets Rx only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL -- 25 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 50 mg (90 Tablets Bottle)

Rising® NDC 57237-205-90
Losartan
Potassium
Tablets USP
50 mg
90 Tablets Rx only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL -- 50 mg (90 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 100 mg (90 Tablets Bottle)

Rising® NDC 57237-206-90
Losartan
Potassium
Tablets USP
100 mg 90 Tablets Rx only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL -- 100 mg (90 Tablets 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:57237-204
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
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
FD&C BLUE NO. 2
D&C YELLOW NO. 10
WATER
Product Characteristics
Color GREEN Score no score
Shape OVAL (Biconvex) Size 8mm
Flavor Imprint Code E;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-204-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-204-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57237-204-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090083 10/06/2010
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-205
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
LACTOSE MONOHYDRATE
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
FD&C BLUE NO. 2
D&C YELLOW NO. 10
WATER
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL (Biconvex) Size 10mm
Flavor Imprint Code E;4;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-205-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-205-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57237-205-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090083 10/06/2010
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-206
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
LACTOSE MONOHYDRATE
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
FD&C BLUE NO. 2
D&C YELLOW NO. 10
WATER
Product Characteristics
Color GREEN Score no score
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code E;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-206-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-206-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57237-206-99 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090083 10/06/2010
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (57237-204), ANALYSIS (57237-205), ANALYSIS (57237-206), MANUFACTURE (57237-204), MANUFACTURE (57237-205), MANUFACTURE (57237-206)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650918514 ANALYSIS (57237-204), ANALYSIS (57237-205), ANALYSIS (57237-206), MANUFACTURE (57237-204), MANUFACTURE (57237-205), MANUFACTURE (57237-206)

Revised: 04/2022 Rising Health, LLC

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