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
NDC Product Code68682-113
Application NumberNDA022301
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Namemesalamine
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