FDA.reportPublic FDA data

Hepsera

Product NDC
46014-0501
11-digit product format
460140501
Labeler code
46014
Product ID
46014-0501_8b66b3f1-06d1-4afa-8bfc-af6c19fcd649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adefovir Dipivoxil
Dosage form
TABLET
Route
ORAL
Labeler
Excella GmbH
Application
NDA021449
Marketing category
NDA
Marketing start
2002-09-20
Marketing end
0000-00-00
Substance
ADEFOVIR DIPIVOXIL
Active strength
10 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
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0eb1706-7ad8-8077-f279-95c62dd67a2cProduct name220180827

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46014-0501-12020-01-31C16284748780-19d75b9d0-2fe6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HEPSERA safely and effectively. See full prescribing information for HEPSERA. HEPSERA (adefovir dipivoxil) tablet for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46014-0501-1Hepsera30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Adefovir DipivoxilACTIVE INGREDIENTU6Q8Z01514HEPSERA (ADEFOVIR DIPIVOXIL) TABLET [EXCELLA GMBH]1
adefovirACTIVE MOIETY6GQP90I798HEPSERA (ADEFOVIR DIPIVOXIL) TABLET [EXCELLA GMBH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46014-0501HEPSERA (ADEFOVIR DIPIVOXIL) TABLET [EXCELLA GMBH]1Legacy NDC, 1 package rows20100624_80595d45-2224-47d1-bd5c-4b11a824e5bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
881341adefovir dipivoxil 10 MG Oral TabletPSN80595d45-2224-47d1-bd5c-4b11a824e5bd1
881343Hepsera 10 MG Oral TabletPSN80595d45-2224-47d1-bd5c-4b11a824e5bd1
881343adefovir dipivoxil 10 MG Oral Tablet [Hepsera]SBD80595d45-2224-47d1-bd5c-4b11a824e5bd1
881341adefovir dipivoxil 10 MG Oral TabletSCD80595d45-2224-47d1-bd5c-4b11a824e5bd1
881343Hepsera 10 MG Oral TabletSY80595d45-2224-47d1-bd5c-4b11a824e5bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46014-0501-14601405010130 in 1 BOTTLE, PLASTICHistorical