Omeprazole and Sodium Bicarbonate

OMEPRAZOLE AND SODIUM BICARBONATE — omeprazole and sodium bicarbonate capsule
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1101-3 in bottle of 30 capsules

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

R_x only

30 capsules

ZYDUS

NDC 70771-1102-3 in bottle of 30 capsules

Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg

R_x only

30 capsules

ZYDUS

OMEPRAZOLE AND SODIUM BICARBONATE omeprazole and sodium bicarbonate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1101 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 GELATIN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA

Product Characteristics Color WHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code 501 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1101-7 14 CAPSULE in 1 BOTTLE None 2 NDC:70771-1101-3 30 CAPSULE in 1 BOTTLE None 3 NDC:70771-1101-9 90 CAPSULE in 1 BOTTLE None 4 NDC:70771-1101-1 100 CAPSULE in 1 BOTTLE None 5 NDC:70771-1101-5 500 CAPSULE in 1 BOTTLE None 6 NDC:70771-1101-0 1000 CAPSULE in 1 BOTTLE None 7 NDC:70771-1101-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1101-2) 7 NDC:70771-1101-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1101-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203290 05/29/2018

OMEPRAZOLE AND SODIUM BICARBONATE omeprazole and sodium bicarbonate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1102 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 GELATIN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA

Product Characteristics Color WHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code 502 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1102-3 30 CAPSULE in 1 BOTTLE None 2 NDC:70771-1102-9 90 CAPSULE in 1 BOTTLE None 3 NDC:70771-1102-1 100 CAPSULE in 1 BOTTLE None 4 NDC:70771-1102-5 500 CAPSULE in 1 BOTTLE None 5 NDC:70771-1102-0 1000 CAPSULE in 1 BOTTLE None 6 NDC:70771-1102-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1102-2) 6 NDC:70771-1102-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1102-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203290 05/29/2018

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (70771-1101), ANALYSIS (70771-1102), MANUFACTURE (70771-1101), MANUFACTURE (70771-1102)

Revised: 10/2022 Zydus Lifesciences Limited