ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
Cadila Healthcare Limited

----------

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES

NDC 70771-1493-3

Esomeprazole Magnesium Delayed-release Capsules, USP

20 mg

30 Capsules

Esomeprazole

NDC 70771-1494-3

Esomeprazole Magnesium Delayed-release Capsules, USP

40 mg

30 Capsules

Esomeprazole
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1493
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (DARK BLUE OPAQUE (CAP)) , WHITE (WHITE OPAQUE (BODY)) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 441;20mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1493-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1493-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1493-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20629605/30/2019
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1494
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE40 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (BLUE OPAQUE (CAP)) , WHITE (OPAQUE WHITE (BODY)) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 442;40mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1494-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1494-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1494-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20629605/30/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1493, 70771-1494) , MANUFACTURE(70771-1493, 70771-1494)

Revised: 9/2020
Document Id: 831599cc-2dc4-4e00-abd1-f736185df6e9
Set id: 6f314f5d-453c-4876-b9b8-20663008dfb1
Version: 2
Effective Time: 20200917
 
Cadila Healthcare Limited