Esomeprazole magnesium
These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
Approved
Approval ID
46d2be17-cfef-4bbe-94d7-15e2b76a0192
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esomeprazole magnesium delayed release capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-8328
Application NumberANDA210559
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole magnesium delayed release capsules
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (18)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 40 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT