FDA.reportPublic FDA data

Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
69238-1548
11-digit product format
692381548
Labeler code
69238
Product ID
69238-1548_16159b02-5612-480f-9089-a60870d60768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209721
Marketing category
ANDA
Marketing start
2018-08-26
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
167 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
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1548-32024-01-30C16284748780-11030e365-3670-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. 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
69238-1548-3Emtricitabine and Tenofovir Disoproxil Fumarate30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1548EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]3Legacy NDC, 1 package rows20200730_70b3deb4-951d-4d9b-a811-be5fa05529a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletPSN70b3deb4-951d-4d9b-a811-be5fa05529a93
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletPSN70b3deb4-951d-4d9b-a811-be5fa05529a93
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletPSN70b3deb4-951d-4d9b-a811-be5fa05529a93
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN70b3deb4-951d-4d9b-a811-be5fa05529a93
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletSCD70b3deb4-951d-4d9b-a811-be5fa05529a93
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletSCD70b3deb4-951d-4d9b-a811-be5fa05529a93
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletSCD70b3deb4-951d-4d9b-a811-be5fa05529a93
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD70b3deb4-951d-4d9b-a811-be5fa05529a93
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY70b3deb4-951d-4d9b-a811-be5fa05529a93
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY70b3deb4-951d-4d9b-a811-be5fa05529a93
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY70b3deb4-951d-4d9b-a811-be5fa05529a93
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY70b3deb4-951d-4d9b-a811-be5fa05529a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1548-36923815480330 TABLET, FILM COATED in 1 BOTTLE (69238-1548-3) 2018-08-260000-00-00NoNoCurrent