Dipentum
(olsalazine sodium)capsule, gelatin coated Rx OnlyCIP70006APT#CIA60342Rev. 1/2014 CIP70006A
Approved
Approval ID
9dd522a3-587e-44ab-9de3-a0fd079f2ffb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2017
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.
olsalazine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-0312
Application NumberNDA019715
Product Classification
M
Marketing Category
C73594
G
Generic Name
olsalazine sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2015
FDA Product Classification
INGREDIENTS (6)
OLSALAZINE SODIUMActive
Quantity: 250 mg in 1 1
Code: Y7JEW0XG7I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT