FDA.reportPublic FDA data

Entecavir

Product NDC
10135-616
11-digit product format
101350616
Labeler code
10135
Product ID
10135-616_ba3e8d2f-b611-4242-9b6b-e0fbc57e64a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA206652
Marketing category
ANDA
Marketing start
2016-03-01
Marketing end
0000-00-00
Substance
ENTECAVIR
Active strength
1 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf657fd6-5fee-0845-3354-1dada0e72202Product name920190701

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-616-302020-01-31C16284748780-19d75b9d0-a45c-f424-e053-dadaa90a57ceThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-616-30Entecavir30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-616-30EA - Each10135-6166eec9de7-711d-426a-8411-b449f8afdc7712016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-616ENTECAVIR TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20160406_aa3d6d9a-ec31-4d66-8151-ec3bfad799e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485434entecavir 0.5 MG Oral TabletPSNaa3d6d9a-ec31-4d66-8151-ec3bfad799e91
485436entecavir 1 MG Oral TabletPSNaa3d6d9a-ec31-4d66-8151-ec3bfad799e91
485434entecavir 0.5 MG Oral TabletSCDaa3d6d9a-ec31-4d66-8151-ec3bfad799e91
485436entecavir 1 MG Oral TabletSCDaa3d6d9a-ec31-4d66-8151-ec3bfad799e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-616-301013506163030 in 1 BOTTLE, PLASTICHistorical