Omeprazole/Bicarbonate (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

NDC 71205-0984-30
Rx Only

Omeprazole and Sodium
Bicarbonate Capsules

20 mg/1100 mg

PHARMACIST: Dispense the accompanyingMedication Guide to each patient.

30 Capsules

71205-984-30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

NDC 71205-985-30
Rx Only

Omeprazole and Sodium
Bicarbonate Capsules

40 mg/1100 mg

PHARMACIST: Dispense the accompanyingMedication Guide to each patient.

30 Capsules

71205-985-30
(click image for full-size original)
OMEPRAZOLE/BICARBONATE omeprazole and sodium bicarbonate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-984(NDC:69367-195)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omeprazole (Omeprazole) Omeprazole 20 mg
Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate 1100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
BUTYL ALCOHOL
TITANIUM DIOXIDE
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Opaque-White) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code SG;363
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-984-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
2 NDC:71205-984-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
3 NDC:71205-984-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207476 07/27/2018
OMEPRAZOLE/BICARBONATE omeprazole and sodium bicarbonate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-985(NDC:69367-196)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omeprazole (Omeprazole) Omeprazole 40 mg
Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate 1100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
BUTYL ALCOHOL
TITANIUM DIOXIDE
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Opaque-White) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code SG;364
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-985-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
2 NDC:71205-985-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
3 NDC:71205-985-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207476 07/27/2018
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-984), REPACK (71205-985), RELABEL (71205-984), RELABEL (71205-985)

Revised: 05/2020 Proficient Rx LP

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