Omeprazole (Page 11 of 11)

Label
(click image for full-size original)
OMEPRAZOLE omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33358-273(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:33358-273-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:33358-273-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:33358-273-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076048 11/11/2003
Labeler — RxChange Co. (781126805)
Establishment
Name Address ID/FEI Operations
RxChange Co. 781126805 repack (33358-273)

Revised: 11/2014 RxChange Co.

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