Delzicol
These highlights do not include all the information needed to use DELZICOL safely and effectively. See full prescribing information for D ELZICOL . DELZICOL (mesalamine) delayed-release capsules, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
71b02324-9430-4269-825f-8fcac5eeaefb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
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 Code0023-5853
Application NumberNDA204412
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Namemesalamine
INGREDIENTS (13)
MESALAMINEActive
Quantity: 400 mg in 1 1
Code: 4Q81I59GXC
Classification: ACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT