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 useInitial U.S. Approval: 2005
Approved
Approval ID
bb1bb6dc-0120-46e2-ad1e-d9afc221fa16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
Solco Healthcare LLC
DUNS: 828343017
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 Code43547-436
Application NumberANDA208782
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENTECAVIR
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
ENTECAVIR ANHYDROUSActive
Quantity: 0.5 mg in 1 1
Code: NNU2O4609D
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ENTECAVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-437
Application NumberANDA208782
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENTECAVIR
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
ENTECAVIR ANHYDROUSActive
Quantity: 1 mg in 1 1
Code: NNU2O4609D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT