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
da705339-c349-444f-a058-4f0cef2864bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2022
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ENTECAVIR
PRODUCT DETAILS
NDC Product Code16714-718
Application NumberANDA206872
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 24, 2022
Generic NameENTECAVIR
INGREDIENTS (10)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
ENTECAVIRActive
Quantity: 1 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ENTECAVIR
PRODUCT DETAILS
NDC Product Code16714-717
Application NumberANDA206872
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 24, 2022
Generic NameENTECAVIR
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
ENTECAVIRActive
Quantity: 0.5 mg in 1 1
Code: 5968Y6H45M
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/7/2018
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 16714-717-01 RX only
Entecavir
Tablets, USP
** 0.5 mg**
30 Tablets
NORTHSTAR
NDC 16714-718-01 RX only
Entecavir
Tablets, USP
** 1 mg**
30 Tablets
NORTHSTAR
