OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole and sodium bicarbonate capsule 
Cadila Healthcare Limited

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OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1101-3 in bottle of 30 capsules

 

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

 

Rx only

 

30 capsules

 

ZYDUS

Omeprazole capsules

NDC 70771-1102-3 in bottle of 30 capsules

 

Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg

 

Rx only

 

30 capsules

 

ZYDUS

omeprazole capsules02
OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorWHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code 501
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1101-714 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
2NDC:70771-1101-330 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
3NDC:70771-1101-990 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
4NDC:70771-1101-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
5NDC:70771-1101-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
6NDC:70771-1101-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
7NDC:70771-1101-410 in 1 CARTON05/29/2018
7NDC:70771-1101-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329005/29/2018
OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE40 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorWHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code 502
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1102-330 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
2NDC:70771-1102-990 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
3NDC:70771-1102-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
4NDC:70771-1102-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
5NDC:70771-1102-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
6NDC:70771-1102-410 in 1 CARTON05/29/2018
6NDC:70771-1102-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20329005/29/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1101, 70771-1102) , MANUFACTURE(70771-1101, 70771-1102)

Revised: 9/2020
Document Id: 2cefef68-af00-40e0-a99f-36fb823d9d3a
Set id: 2fdb0934-5bf4-47c6-8368-2dbaaabd4b8d
Version: 4
Effective Time: 20200908
 
Cadila Healthcare Limited