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
8aff9f54-62e1-4ce7-8cc0-dea1195e4006
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-6450
Application NumberANDA078003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
FDA Product Classification
INGREDIENTS (14)
ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 36H71644EQ
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Esomeprazole Magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-6451
Application NumberANDA078003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
FDA Product Classification
INGREDIENTS (14)
ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive
Quantity: 40 mg in 1 1
Code: 36H71644EQ
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT