Omeprazole and Sodium Bicrabonate (Page 10 of 10)

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Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg — Container Label

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Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg — Container Label

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OMEPRAZOLE AND SODIUM BICRABONATE omeprazole and sodium bicrabonate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-363
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
silicon dioxide
sodium stearyl fumarate
gelatin
SODIUM LAURYL SULFATE
titanium dioxide
Potassium hydroxide
propylene glycol
ammonia
SHELLAC
Product Characteristics
Color WHITE (opaque white colored body and cap) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code RDY;363
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-363-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-363-01 100 CAPSULE in 1 BOTTLE None
3 NDC:55111-363-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204068 07/15/2016
OMEPRAZOLE AND SODIUM BICRABONATE omeprazole and sodium bicrabonate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-364
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
silicon dioxide
sodium stearyl fumarate
gelatin
SODIUM LAURYL SULFATE
titanium dioxide
Potassium hydroxide
FD&C BLUE NO. 1
FD&C RED NO. 40
propylene glycol
shellac
ammonia
Product Characteristics
Color WHITE (opaque white colored body) , BLUE (blue colored cap) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code RDY;364
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-364-30 30 CAPSULE in 1 BOTTLE None
2 NDC:55111-364-01 100 CAPSULE in 1 BOTTLE None
3 NDC:55111-364-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204068 07/15/2016
Labeler — Dr.Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO 3 918608162 analysis (55111-363), manufacture (55111-363), analysis (55111-364), manufacture (55111-364)

Revised: 03/2022 Dr.Reddy’s Laboratories Limited

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