Mesalamine
MESALAMINE SUPPOSITORIES
Approved
Approval ID
aa63b4bb-2de7-40aa-b26b-1b00b0183eac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1513
Application NumberANDA208953
Marketing CategoryC73584
Route of AdministrationRECTAL
Effective DateOctober 31, 2022
Generic NameMesalamine
INGREDIENTS (2)
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT
MESALAMINEActive
Quantity: 1000 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 2/13/2020
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1513-6
Mesalamine suppositories, 1000 mg
30 rectal suppositories
Rx only
Image
NDC 70771-1513-7
Mesalamine rectal suppositories, 1000 mg
30 rectal suppositories
Rx only
Image
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/4/2020