NDC Code(s) : 50090-3655-1, 50090-3655-0
Packager : A-S Medication Solutions

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Olmesartan Medoxomil Olmesartan Medoxomil TABLET, COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:50090-3655(NDC:67877-447)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10) 		OLMESARTAN MEDOXOMIL40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
STEARIC ACID(UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oval shape) Size 15 mm
Flavor Imprint Code OLM;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-3655-190 in 1 BOTTLE Type 0: Not a Combination Product10/11/2018
2NDC:50090-3655-030 in 1 BOTTLE Type 0: Not a Combination Product10/11/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206763 04/24/2017

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3655), REPACK(50090-3655)

PRINCIPAL DISPLAY PANEL

Label Image