Entecavir
These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
007a6ad8-4d23-4543-ae48-c651cac7dd7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2019
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-449
Application NumberANDA206652
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ENTECAVIRActive
Quantity: 1 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
Entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-446
Application NumberANDA206652
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (9)
ENTECAVIRActive
Quantity: 0.5 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT