FDA.reportPublic FDA data

Truvada

Product NDC
50090-0870
11-digit product format
500900870
Labeler code
50090
Product ID
50090-0870_cb9a6580-9a40-4659-a9ac-0e918e645524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021752
Marketing category
NDA
Marketing start
2004-08-02
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0870-02023-01-30C16284748780-1f386c64a-0a24-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
50090-0870-22023-01-30C16284748780-1f386c64a-0a24-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
50090-0870-32023-01-30C16284748780-1f386c64a-0a24-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0870-0Truvada30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3012
50090-0870-2Truvada5 in 1 BOTTLETABLET, FILM COATED512
50090-0870-3Truvada3 in 1 BOTTLETABLET, FILM COATED312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0870-0EA - Each50090-0870f1db03f5-6ef4-4d89-a571-68b353aabc9912018-10-11
50090-0870-2EA - Each50090-087069cc1779-1267-4d68-b2b0-6e7a975b768112018-10-11
50090-0870-3EA - Each50090-08703b4272cb-f628-41d7-b205-5d555180597512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0870TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Legacy NDC, 3 package rows20210616_00b4b5b5-7220-410c-8db2-dd940498cfc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN00b4b5b5-7220-410c-8db2-dd940498cfc212
639888Truvada 200 MG / 300 MG Oral TabletPSN00b4b5b5-7220-410c-8db2-dd940498cfc212
639888emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]SBD00b4b5b5-7220-410c-8db2-dd940498cfc212
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD00b4b5b5-7220-410c-8db2-dd940498cfc212
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY00b4b5b5-7220-410c-8db2-dd940498cfc212
639888Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral TabletSY00b4b5b5-7220-410c-8db2-dd940498cfc212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0870-05009008700030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0870-0) 2014-11-280000-00-00NoNoCurrent
50090-0870-2500900870025 TABLET, FILM COATED in 1 BOTTLE (50090-0870-2) 2014-11-280000-00-00NoNoCurrent
50090-0870-3500900870033 TABLET, FILM COATED in 1 BOTTLE (50090-0870-3) 2014-11-280000-00-00NoNoCurrent