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
9224142a-6e14-4ca3-9e72-506ff9fbd0e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-143
Application NumberANDA078279
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (20)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Esomeprazole MagnesiumActive
Quantity: 40 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Methacrylic AcidInactive
Code: 1CS02G8656
Classification: IACT