mesalamine
These highlights do not include all the information needed to use MESALAMINE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MESALAMINE EXTENDED-RELEASE CAPSULES. MESALAMINE extended-release capsules Initial U.S. Approval: 1987
Approved
Approval ID
cfe4800f-868f-46fd-8b9a-977a91ae5fbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
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 Code68682-113
Application NumberNDA022301
Product Classification
M
Marketing Category
C73605
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MESALAMINEActive
Quantity: 375 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT