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 use ISENTRESS (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
b05735be-d278-4c31-bfb5-ebf74ce42b89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-214
Application NumberNDA022145
Product Classification
M
Marketing Category
C73594
G
Generic Name
RALTEGRAVIR
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2013
FDA Product Classification
INGREDIENTS (15)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
RALTEGRAVIR POTASSIUMActive
Quantity: 400 mg in 1 1
Code: 43Y000U234
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT