ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium granule, delayed release 
Zydus Lifesciences Limited

----------

ESOMEPRAZOLE MAGNESIUM for delayed-release oral suspension

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-1

20 mg packet

Rx Only

20 mg packet

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-3 unit dose packages of 30: 20 mg packets

Rx Only

20 mg carton

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-1

40 mg packet

Rx Only

40 mg packet

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-3 unit dose packages of 30: 40 mg packets

Rx Only

40 mg carton
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium granule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1391
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE (UNII: IY9XDZ35W2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1391-330 in 1 CARTON; Type 0: Not a Combination Product06/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20605506/30/2023
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium granule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1392
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE (UNII: IY9XDZ35W2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (TYPE E) (UNII: 66O7AQV0RT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBROWN (WHITE TO PALE BROWN) , RED (PALE RED TO RED) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1392-330 in 1 CARTON; Type 0: Not a Combination Product06/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20605506/30/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1391, 70771-1392) , MANUFACTURE(70771-1391, 70771-1392)

Revised: 11/2024
Document Id: 983313a8-2120-4c76-8412-0c0c6a159465
Set id: 4cd9e802-c519-4593-bc38-947ad7f9b567
Version: 2
Effective Time: 20241128
 
Zydus Lifesciences Limited