ISENTRESS
These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) film-coated tablets, for oral useISENTRESS HD (raltegravir) film-coated tablets, for oral useISENTRESS (raltegravir) chewable tablets, for oral useISENTRESS (raltegravir) for oral suspensionInitial U.S. Approval: 2007
Approved
Approval ID
7e659505-c902-4906-9461-1cc83e2236d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2023
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.
RALTEGRAVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1085
Application NumberNDA022145
Product Classification
M
Marketing Category
C73594
G
Generic Name
RALTEGRAVIR
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (15)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
RALTEGRAVIR POTASSIUMActive
Quantity: 400 mg in 1 1
Code: 43Y000U234
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT