Truvada

Product NDC
67296-1237
11-digit product format
672961237
Labeler code
67296
Product ID
67296-1237_d6102263-b02a-015c-e053-2995a90a5370
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Truvada
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, 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
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1237-3Truvada3 in 1 BOTTLETABLET, FILM COATED34
67296-1237-4Truvada4 in 1 BOTTLETABLET, FILM COATED44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1237TRUVADA TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240716_4f4268c2-42aa-49fa-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN4f4268c2-42aa-49fa-e054-00144ff88e884
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD4f4268c2-42aa-49fa-e054-00144ff88e884
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY4f4268c2-42aa-49fa-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1237-3672961237033 TABLET, FILM COATED in 1 BOTTLE (67296-1237-3) 2004-08-020000-00-00NoNoCurrent
67296-1237-4672961237044 TABLET, FILM COATED in 1 BOTTLE (67296-1237-4) 2004-08-020000-00-00NoNoCurrent