Dolutegravir
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Approved
Approval ID
1b045960-02a9-45a2-8393-66c0f8da58ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 5, 2021
Manufacturers
FDA
Mylan Laboratories Limited
DUNS: 650547156
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dolutegravir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65015-353
Product Classification
G
Generic Name
Dolutegravir
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2021
FDA Product Classification
INGREDIENTS (15)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DOLUTEGRAVIR SODIUMActive
Quantity: 10 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT