Losartan Potassium (Page 8 of 8)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 50 mg (30 Tablets)

losart50
(click image for full-size original)
NDC 67046-455-30 Rx only
Losartan Potassium Tablets USP
50 mg
AUROBINDO 30 Tablets

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 100 mg (30 Tablets)

lsart100
(click image for full-size original)
NDC 67046-449-30 Rx only
Losartan Potassium Tablets USP
100 mg AUROBINDO 30 Tablets

LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-455(NDC:65862-202)
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
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE
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:67046-455-30 30 TABLET, FILM COATED in 1 BLISTER PACK 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:67046-449(NDC:65862-203)
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
LACTOSE MONOHYDRATE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE
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:67046-449-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090083 10/06/2010
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises 945429777 repack (67046-449), repack (67046-455)

Revised: 12/2018 Contract Pharmacy Services-PA

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