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
cd20c321-5348-4c25-8099-e0a611449b06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
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 Code13668-155
Application NumberANDA203636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESOMEPRAZOLE MAGNESIUM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (20)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
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
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 40 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
ESOMEPRAZOLE MAGNESIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-154
Application NumberANDA203636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESOMEPRAZOLE MAGNESIUM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (19)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 20 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT