NDC Code(s) : 50090-3107-0, 50090-3107-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Olmesartan MedoxomilOlmesartan Medoxomil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3107(NDC:0093-7611)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10) 		OLMESARTAN MEDOXOMIL20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(UNII: NZ94SDL6WR)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)(UNII: 7773C1ROEU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code TV;B4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-3107-030 in 1 BOTTLE Type 0: Not a Combination Product08/02/2017
2NDC:50090-3107-190 in 1 BOTTLE Type 0: Not a Combination Product26/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091079 04/24/2017

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3107), REPACK(50090-3107)

PRINCIPAL DISPLAY PANEL

Label Image