Omeprazole (Page 11 of 11)

OMEPRAZOLE CAPSULE, DELAYED RELEASE

Label Image
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OMEPRAZOLE omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-3088(NDC:60505-0065)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (Omeprazole) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM HYDROXIDE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POVIDONE K30
TRIETHYL CITRATE
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PINK (opaque) , BROWN (reddish brown) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APO;020
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-3088-8 .00001 CAPSULE, DELAYED RELEASE in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076048 11/11/2003
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-3088)

Revised: 01/2015 Carilion Materials Management

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