Delzicol
These highlights do not include all the information needed to use DELZICOL safely and effectively. See full prescribing information for DELZICOL. DELZICOL (mesalamine) delayed-release capsules, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
3479cbf1-434e-417f-be73-7c75139013f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-5652
Application NumberNDA204412
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesalamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2014
FDA Product Classification
INGREDIENTS (13)
MESALAMINEActive
Quantity: 400 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT