Entecavir

Basic Information

Product Name

Entecavir

FDA Product Code

42806-658

Regulatory Information

NDC Product Code

42806-658

Application Number

ANDA212126

Marketing Category

C73584

Effective Date

June 2, 2020

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ENTECAVIR

Quantity: 0.5 mg in 1 1

Code: 5968Y6H45M

Class Code: ACTIB

Active Moieties

ENTECAVIR ANHYDROUS

Code: NNU2O4609D

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

HYPROMELLOSES

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

POLYETHYLENE GLYCOL

MICROCRYSTALLINE CELLULOSE

TITANIUM DIOXIDE

Active Moieties

ENTECAVIR ANHYDROUS