ISENTRESS
ISENTRESS
Approved
Approval ID
9000a7ea-efce-3fba-e053-2a95a90ae2c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2021
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ISENTRESS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-706
Application NumberNDA022145
Product Classification
M
Marketing Category
C73594
G
Generic Name
ISENTRESS
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2021
FDA Product Classification
INGREDIENTS (15)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RALTEGRAVIR POTASSIUMActive
Quantity: 400 mg in 1 1
Code: 43Y000U234
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT