Esomeprazole Magnesium
ESOMEPRAZOLE MAGNESIUM for delayed-release oral suspension
Approved
Approval ID
4cd9e802-c519-4593-bc38-947ad7f9b567
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esomeprazole Magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1391
Application NumberANDA206055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (17)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 36H71644EQ
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Esomeprazole Magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1392
Application NumberANDA206055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (17)
ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive
Quantity: 40 mg in 1 1
Code: 36H71644EQ
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT