NDC Code(s) : 70000-0232-1, 70000-0232-2, 70000-0232-3
Packager : LEADER/ Cardinal Health 110, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acid ReducerOmeprazole Magnesium CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0232(NDC:55111-397)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
Gelatin(UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
Magnesium Oxide(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A(UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Polysorbate 80(UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
RAW SUGAR(UNII: 8M707QY5GH)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Sodium Lauryl Sulfate(UNII: 368GB5141J)
Product Characteristics
Color WHITE, PINK Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code OMP20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70000-0232-11 in 1 CARTON 03/07/2017
1NDC:70000-0232-22 in 1 CARTON 03/07/2017
1NDC:70000-0232-33 in 1 CARTON 03/07/2017
114 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 ANDA078878 03/07/2017

LABELER - LEADER/ Cardinal Health 110, Inc.(063997360)

PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0232-1

Acid Reducer
Omeprazole
Delayed-release Capsules, 20 mg*

Treats Frequent Heartburn

14 DELAYED-RELEASE CAPSULES
One 14-Day Course of Treamtent

May take 1 to 4 days for full effect

COMPARE TO
PRILOSEC OTC®
active ingredient**

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PRINCIPAL DISPLAY PANEL

LEADER™
NDC 70000-0232-1

Acid Reducer  
Omeprazole  
Delayed-release Capsules, 20 mg*

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 DELAYED-RELEASE CAPSULES  
One 14-Day Course of Treatmen t