Mesalamine
These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-408
Application NumberANDA203286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (17)
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MESALAMINEActive
Quantity: 800 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB