FDA.reportPublic FDA data

Entecavir

Product NDC
65862-842
11-digit product format
658620842
Labeler code
65862
Product ID
65862-842_81e4395b-8a3e-466e-b039-0a804f171b43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206217
Marketing category
ANDA
Marketing start
2015-08-26
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
bf657fd6-5fee-0845-3354-1dada0e72202Product name920190701

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-842-30Entecavir1 in 1 CARTONTABLET19
65862-842-30Entecavir30 in 1 BOTTLETABLET309
65862-842-90Entecavir90 in 1 BOTTLETABLET909
65862-842-90Entecavir1 in 1 CARTONTABLET19
65862-842-99Entecavir1000 in 1 BOTTLETABLET10009
65862-842-99Entecavir1 in 1 CARTONTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-842-30EA - Each65862-842977d3f3b-aded-4c86-b1c1-1ce6c0203f6112015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENTECAVIRACTIVE INGREDIENT5968Y6H45MENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
ENTECAVIR ANHYDROUSACTIVE MOIETYNNU2O4609DENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-842ENTECAVIR TABLET [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 6 package rows20231124_def332bf-2906-4a6c-b85d-dfb56bb94312.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485434entecavir 0.5 MG Oral TabletPSNdef332bf-2906-4a6c-b85d-dfb56bb943129
485436entecavir 1 MG Oral TabletPSNdef332bf-2906-4a6c-b85d-dfb56bb943129
485434entecavir 0.5 MG Oral TabletSCDdef332bf-2906-4a6c-b85d-dfb56bb943129
485436entecavir 1 MG Oral TabletSCDdef332bf-2906-4a6c-b85d-dfb56bb943129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-842-30658620842301 BOTTLE in 1 CARTON (65862-842-30) / 30 TABLET in 1 BOTTLE1 bottle2015-08-260000-00-00NoNoCurrent
65862-842-90658620842901 BOTTLE in 1 CARTON (65862-842-90) / 90 TABLET in 1 BOTTLE1 bottle2015-08-260000-00-00NoNoCurrent
65862-842-99658620842991 BOTTLE in 1 CARTON (65862-842-99) / 1000 TABLET in 1 BOTTLE1 bottle2015-08-260000-00-00NoNoCurrent