Priftin
These highlights do not include all the information needed to use PRIFTIN safely and effectively. See full prescribing information for PRIFTIN. PRIFTIN (rifapentine) tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
1502544d-1b3a-46bd-84f5-af92cab72ce8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rifapentine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-5063
Application NumberNDA021024
Product Classification
M
Marketing Category
C73594
G
Generic Name
rifapentine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2018
FDA Product Classification
INGREDIENTS (16)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RIFAPENTINEActive
Quantity: 150 mg in 1 1
Code: XJM390A33U
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT