NDC Code(s) : 58602-826-05, 58602-826-61, 58602-826-62
Packager : Aurohealth LLC

Category : Human OTC Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acid Reducer Omeprazole TABLET, DELAYED RELEASE
Product Information
Product Type Human OTC Drug Label Item Code (Source) NDC:58602-826
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM(UNII: 426QFE7XLK)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (35 .MU.M)(UNII: 40UAA97IT9)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (45000 WAMW)(UNII: 8VAB711C5E)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
Product Characteristics
Color PINK Score no score
Shape RECTANGLE (Oblong) Size 14 mm
Flavor Imprint Code Z;69
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58602-826-051 in 1 CARTON 06/06/2018
114 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:58602-826-612 in 1 CARTON 06/06/2018
214 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:58602-826-623 in 1 CARTON 06/06/2018
314 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206877 06/06/2018

LABELER - Aurohealth LLC(078728447)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(58602-826), MANUFACTURE(58602-826)

PRINCIPAL DISPLAY PANEL

NDC 58602-826-05         PrimaryHealth
See current Drug Facts
Acid Reducer
Omeprazole Delayed-Release
Tablets 20 mg
 Treats Frequent Heartburn!
24 HR
14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

PRINCIPAL DISPLAY PANEL

NDC 58602-826-05
PrimaryHealth
COMPARE TO Prilosec OTC®
Active ingredient*
See current Drug Facts
ACID REDUCER
Omeprazole
 Delayed-Release
Tablets 20 mg
 Treats Frequent Heartburn!
 24 HR
 14 TABLETS
One 14-day Course of Treatment
May take 1 to 4 days for full effect



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label