APRISO
These highlights do not include all the information needed to use APRISO safely and effectively. See full prescribing information for APRISO. APRISO (mesalamine) extended-release capsules Initial U.S. Approval: 1987
Approved
Approval ID
7951139c-b271-45a4-b523-34b23800917b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Salix Pharmaceuticals, Inc.
DUNS: 793108036
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mesalamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65649-103
Application NumberNDA022301
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MESALAMINEActive
Quantity: 375 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT