SELZENTRY
These highlights do not include all the information needed to use SELZENTRY safely and effectively. See full prescribing information for SELZENTRY. SELZENTRY (maraviroc) tablets, for oral useSELZENTRY (maraviroc) oral solutionInitial U.S. Approval: 2007
Approved
Approval ID
46f30ac5-c96b-429e-976d-8c5ee1c0761b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2022
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 6
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 Code49702-237
Application NumberNDA208984
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MARAVIROCActive
Quantity: 20 mg in 1 mL
Code: MD6P741W8A
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-224
Application NumberNDA022128
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (12)
MARAVIROCActive
Quantity: 300 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-260
Application NumberNDA208984
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Effective DateSeptember 26, 2022
FDA Product Classification
maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-223
Application NumberNDA022128
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MARAVIROCActive
Quantity: 150 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-235
Application NumberNDA022128
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MARAVIROCActive
Quantity: 75 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-233
Application NumberNDA022128
Product Classification
M
Marketing Category
C73594
G
Generic Name
maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (12)
MARAVIROCActive
Quantity: 25 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT