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
cceffe6d-d0c3-40c6-b077-478a623e5370
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2021
Manufacturers
FDA
YUNG SHIN PHARM. IND. CO., LTD.
DUNS: 656108149
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 Code63126-101
Application NumberANDA208195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2021
FDA Product Classification
INGREDIENTS (9)
ENTECAVIRActive
Quantity: 0.5 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Entecavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63126-102
Application NumberANDA208195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2021
FDA Product Classification
INGREDIENTS (10)
ENTECAVIRActive
Quantity: 1 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT