This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Entecavir

Read time: 1 mins
Marketing start date: 28 Dec 2024
...
 

Summary of product characteristics


Effective Time

20220826

Version

5

Spl Product Data Elements

Entecavir Entecavir ENTECAVIR ENTECAVIR ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 920 Entecavir Entecavir ENTECAVIR ENTECAVIR ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE LIGHT-PINK TO PINK ROUND 921

Application Number

ANDA206745

Brand Name

Entecavir

Generic Name

Entecavir

Product Ndc

70771-1020

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Entecavir tablets Entecavir tablets

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.