NDC Code(s) : 50090-6537-0, 50090-6537-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6537(NDC:16729-366)
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
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(UNII: NZ94SDL6WR)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (reddish-yellow) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code OH1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-6537-030 in 1 BOTTLE Type 0: Not a Combination Product28/06/2023
2NDC:50090-6537-190 in 1 BOTTLE Type 0: Not a Combination Product28/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209281 09/21/2020

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-6537)

PRINCIPAL DISPLAY PANEL

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