Entecavir

Product NDC
42291-262
11-digit product format
422910262
Labeler code
42291
Product ID
42291-262_d57a808f-0045-5d84-e053-2995a90a74ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA206652
Marketing category
ANDA
Marketing start
2020-11-02
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-262-30Entecavir30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-262-30EA - Each42291-262a516ecab-f50d-4849-9579-e0004c580fe612016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-262ENTECAVIR TABLET, FILM COATED [AVKARE]11Legacy NDC, 1 package rows20240110_5a1cbf7e-0352-aa3b-080c-222a6423ecd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485434entecavir 0.5 MG Oral TabletPSN5a1cbf7e-0352-aa3b-080c-222a6423ecd813
485436entecavir 1 MG Oral TabletPSN5a1cbf7e-0352-aa3b-080c-222a6423ecd813
485434entecavir 0.5 MG Oral TabletSCD5a1cbf7e-0352-aa3b-080c-222a6423ecd813
485436entecavir 1 MG Oral TabletSCD5a1cbf7e-0352-aa3b-080c-222a6423ecd813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-262-304229102623030 TABLET, FILM COATED in 1 BOTTLE (42291-262-30) 2020-11-020000-00-00NoNoCurrent