Omeprazole (Page 12 of 12)

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OMEPRAZOLE omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-265(NDC:55111-158)
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
crospovidone
hypromelloses
magnesium stearate
mannitol
meglumine
methacrylic acid — ethyl acrylate copolymer (1:1) type A
shellac
poloxamer 407
povidone
triethyl citrate
D&C Red No. 28
FD&C Blue No. 1
FD&C Red No. 40
FD&C Yellow No. 6
ferric oxide yellow
gelatin
silicon dioxide
sodium lauryl sulfate
titanium dioxide
butyl alcohol
propylene glycol
Product Characteristics
Color WHITE (off-white to pale yellow) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Omepraole;20mg;R158
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49999-265-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:49999-265-15 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:49999-265-28 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:49999-265-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:49999-265-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
6 NDC:49999-265-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
7 NDC:49999-265-00 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
8 NDC:49999-265-01 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/13/2010
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 repack (49999-265)

Revised: 04/2020 Quality Care Products, LLC

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