Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sanofi S.r.l.
sanofi-aventis U.S. LLC
338454274
EUROAPI ITALY SRL
sanofi-aventis U.S. LLC
441356580
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Priftin
Product Details
NDC Product Code
0088-2102Application Number
NDA021024Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 6, 2018RifapentineActive
Code: XJM390A33UClass: ACTIBQuantity: 150 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT