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
09ec3e79-c0d3-4b8f-80d8-0a854c4ca339
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2022
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-580
Application NumberANDA203347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2022
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MARAVIROCActive
Quantity: 300 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
Maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-579
Application NumberANDA203347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2022
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MARAVIROCActive
Quantity: 150 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT