Mesalamine
These highlights do not include all the information needed to use MESALAMINE SUPPOSITORIES safely and effectively. See full prescribing information for MESALAMINE SUPPOSITORIES. MESALAMINE suppositories, for rectal use Initial U.S. Approval: 1987
Approved
Approval ID
de981df1-747a-480d-a866-e72332a1544d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2019
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
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 Code64980-282
Application NumberANDA207448
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mesalamine
Product Specifications
Route of AdministrationRECTAL
Effective DateJune 5, 2019
FDA Product Classification
INGREDIENTS (2)
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB