FDA.reportPublic FDA data

tenofovir disoproxil fumarate

Product NDC
33342-096
11-digit product format
333420096
Labeler code
33342
Product ID
33342-096_9826ed5e-829c-4e94-9c60-761acb892d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203232
Marketing category
ANDA
Marketing start
2018-01-26
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tenofovir disoproxil fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOTT9J7900I
Rxcui349251

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-096-07tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-096-07EA - Each33342-096bda968a5-8a20-467b-9454-5a44e4312dca12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-096TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 1 package rows20250306_532755cb-1cd3-4774-97af-05a53779b65f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSN532755cb-1cd3-4774-97af-05a53779b65f9
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCD532755cb-1cd3-4774-97af-05a53779b65f9
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY532755cb-1cd3-4774-97af-05a53779b65f9
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNda78a5d3-f5c6-47fe-b593-3252704c225d6
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDda78a5d3-f5c6-47fe-b593-3252704c225d6
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYda78a5d3-f5c6-47fe-b593-3252704c225d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-096-073334200960730 TABLET, FILM COATED in 1 BOTTLE (33342-096-07) 2018-01-260000-00-00NoNoCurrent