42806-658 NDC - ENTECAVIR

Drug Information

Product NDC: 42806-658
Proprietary Name: Entecavir
Non Proprietary Name: Entecavir
Active Ingredient(s): .5 mg/1 ENTECAVIR
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Nucleoside Analog [EXT]; Nucleoside Reverse Transcriptase Inhibitors [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	EPIC PHARMA, LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA212126
Marketing Category:	ANDA
Start Marketing Date:	6/2/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	42806-658-30	30 TABLET in 1 BOTTLE, PLASTIC (42806-658-30)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	42806-658	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	The translation of the route code submitted by the firm, indicating route of administration.
PROPRIETARY NAME	Entecavir	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NON PROPRIETARY NAME	Entecavir	Name of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAME	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	6/2/2020	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
MARKETING CATEGORY NAME	ANDA	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	ANDA212126	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	EPIC PHARMA, LLC	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
SUBSTANCE NAME	ENTECAVIR	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ACTIVE NUMERATOR STRENGTH	.5
ACTIVE INGRED UNIT	mg/1	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
PHARM CLASSES	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]

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This page was last updated on: 12/6/2025

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