FDA.reportPublic FDA data

Truvada

Product NDC
52959-969
11-digit product format
529590969
Labeler code
52959
Product ID
52959-969_33319495-9b23-4a6e-8473-226da2b5d927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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
Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
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
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
52959-969-032019-11-13C16284748780-197449f38-ba9e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-969-03Truvada30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-969-03EA - Each52959-9698e50daf2-5178-4791-bc09-cdb8ea7a1d5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
emtricitabineACTIVE INGREDIENTG70B4ETF4STRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
tenofovir disoproxil fumarateACTIVE INGREDIENTOTT9J7900ITRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
emtricitabineACTIVE MOIETYG70B4ETF4STRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
tenofovirACTIVE MOIETY99YXE507ILTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-969TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111215_7fbc31c3-48d3-4508-8717-1cdfbf085b4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN7fbc31c3-48d3-4508-8717-1cdfbf085b4d2
639888Truvada 200 MG / 300 MG Oral TabletPSN7fbc31c3-48d3-4508-8717-1cdfbf085b4d2
639888emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]SBD7fbc31c3-48d3-4508-8717-1cdfbf085b4d2
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD7fbc31c3-48d3-4508-8717-1cdfbf085b4d2
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY7fbc31c3-48d3-4508-8717-1cdfbf085b4d2
639888Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral TabletSY7fbc31c3-48d3-4508-8717-1cdfbf085b4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-969-035295909690330 in 1 BOTTLE, PLASTICHistorical