FDA.reportPublic FDA data

ADEFOVIR DIPIVOXIL

Product NDC
42794-003
11-digit product format
427940003
Labeler code
42794
Product ID
42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ADEFOVIR DIPIVOXIL
Dosage form
TABLET
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA202051
Marketing category
ANDA
Marketing start
2013-09-03
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
a0eb1706-7ad8-8077-f279-95c62dd67a2cProduct name220180827

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42794-003-08ADEFOVIR DIPIVOXIL30 in 1 BOTTLETABLET308
42794-003-08ADEFOVIR DIPIVOXIL1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-003-08EA - Each42794-00323e37e2f-e7ed-40a8-9ab4-7e993abb85d612013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADEFOVIR DIPIVOXILACTIVE INGREDIENTU6Q8Z01514ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
ADEFOVIRACTIVE MOIETY6GQP90I798ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-003ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC]8Current NDC, Legacy NDC, 2 package rows20230325_e047f3b2-feae-4c5e-9d07-1fefb4c0ec25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
881341adefovir dipivoxil 10 MG Oral TabletPSNe047f3b2-feae-4c5e-9d07-1fefb4c0ec258
881341adefovir dipivoxil 10 MG Oral TabletSCDe047f3b2-feae-4c5e-9d07-1fefb4c0ec258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-003-08427940003081 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLE1 bottle2016-07-180000-00-00NoNoCurrent