Adefovir dipivoxil

Product NDC
60505-3947
11-digit product format
605053947
Labeler code
60505
Product ID
60505-3947_bd0233d0-e141-a321-66a5-4afd09dbabfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adefovir dipivoxil
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA205459
Marketing category
ANDA
Marketing start
2018-09-25
Marketing end
2026-11-30
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
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adefovir dipivoxil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADEFOVIR DIPIVOXIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6Q8Z01514
Rxcui881341

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a0eb1706-7ad8-8077-f279-95c62dd67a2cProduct name220180827

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3947-3Adefovir dipivoxil1 in 1 CARTONTABLET18
60505-3947-3Adefovir dipivoxil30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3947-3EA - Each60505-3947f666cf0b-d8c3-43e3-ab15-a23e1fa3b72e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3947ADEFOVIR DIPIVOXIL TABLET [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20250412_08e07fae-3191-b6a3-c894-d3a8cc53923f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
881341adefovir dipivoxil 10 MG Oral TabletPSN08e07fae-3191-b6a3-c894-d3a8cc53923f8
881341adefovir dipivoxil 10 MG Oral TabletSCD08e07fae-3191-b6a3-c894-d3a8cc53923f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3947-3605053947031 BOTTLE in 1 CARTON (60505-3947-3) / 30 TABLET in 1 BOTTLE1 bottle2018-09-252026-11-30NoNoCurrent