Omeprazole (Page 15 of 15)

Principal Display Panel

NDC: 70934-479-60

Label
(click image for full-size original)

NDC: 70934-486-60

Label
(click image for full-size original)
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-479(NDC:62175-118)
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
GLYCERYL DIBEHENATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
GELATIN
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
SHELLAC
FERRIC OXIDE YELLOW
AMMONIA
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL
ALCOHOL
Product Characteristics
Color white (opaque white cap) , yellow (opaque gold body) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code KU;118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-479-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:70934-479-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075410 12/31/2019
OMEPRAZOLE
omeprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-486(NDC:62175-136)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
GELATIN
GLYCERYL DIBEHENATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE YELLOW
SHELLAC
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
AMMONIA
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL
ALCOHOL
Product Characteristics
Color yellow (opaque gold cap) , yellow (opaque gold body) Score no score
Shape CAPSULE (capsule) Size 22mm
Flavor Imprint Code KU;136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-486-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:70934-486-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:70934-486-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075410 01/07/2020
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-479), repack (70934-486)

Revised: 03/2020 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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