FDA.reportPublic FDA data

ENTECAVIR

Product NDC
50771-014
11-digit product format
507710014
Labeler code
50771
Product ID
50771-014_4502e388-5064-bd87-e063-6294a90a4b1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
entecavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Yaopharma Co., Ltd.
Application
ANDA212201
Marketing category
ANDA
Marketing start
2023-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ENTECAVIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENTECAVIR1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5968Y6H45M
Rxcui485434, 485436

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bf657fd6-5fee-0845-3354-1dada0e72202Product name920190701
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50771-014-012024-06-24C16284748780-11030e365-089c-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION 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
50771-014-012024-01-30C16284748780-11030e365-089c-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50771-014-01ENTECAVIR30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50771-014ENTECAVIR TABLET, FILM COATED [YAOPHARMA CO., LTD.]10Current NDC, Legacy NDC, 1 package rows20241220_73dea2a4-a596-477f-b66d-5a80dd019837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485434entecavir 0.5 MG Oral TabletPSN73dea2a4-a596-477f-b66d-5a80dd01983712
485436entecavir 1 MG Oral TabletPSN73dea2a4-a596-477f-b66d-5a80dd01983712
485434entecavir 0.5 MG Oral TabletSCD73dea2a4-a596-477f-b66d-5a80dd01983712
485436entecavir 1 MG Oral TabletSCD73dea2a4-a596-477f-b66d-5a80dd01983712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50771-014-015077100140130 TABLET, FILM COATED in 1 BOTTLE (50771-014-01) 2023-07-010000-00-00NoNoCurrent