NDC Code(s) : 71610-465-30, 71610-465-60
Packager : Aphena Pharma Solutions - Tennessee, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LOSARTAN POTASSIUMLOSARTAN POTASSIUM TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-465(NDC:72865-143)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM(UNII: 3ST302B24A)
(LOSARTAN - UNII:JMS50MPO89) 		LOSARTAN POTASSIUM100 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape TEAR Size 12 mm
Flavor Imprint Code T;7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71610-465-3030 in 1 BOTTLE Type 0: Not a Combination Product15/09/2020
2NDC:71610-465-6090 in 1 BOTTLE Type 0: Not a Combination Product15/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203835 03/13/2020

LABELER - Aphena Pharma Solutions - Tennessee, LLC(128385585)

Establishment
Name Address ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-465)

PRINCIPAL DISPLAY PANEL

NDC 71610-465 - Losartan Potassium, USP 100 mg Tablets - Rx Only
Bottle Label 100 mg