Maraviroc
These highlights do not include all the information needed to use MARAVIROC TABLETS safely and effectively. See full prescribing information for MARAVIROC TABLETS. MARAVIROC tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
d3a728e2-1866-462e-bfcc-5f3c9dd88794
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
XLCare Pharmaceuticals Inc.
DUNS: 080991142
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Maraviroc
PRODUCT DETAILS
NDC Product Code72865-232
Application NumberANDA203347
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2023
Generic NameMaraviroc
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MARAVIROCActive
Quantity: 300 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
Maraviroc
PRODUCT DETAILS
NDC Product Code72865-231
Application NumberANDA203347
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2023
Generic NameMaraviroc
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MARAVIROCActive
Quantity: 150 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB