FDA.reportPublic FDA data

Truvada

Product NDC
61958-0704
11-digit product format
619580704
Labeler code
61958
Product ID
61958-0704_32422ee8-1cdc-4305-bb3e-0458472513fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Gilead Sciences, Inc
Application
NDA021752
Marketing category
NDA
Marketing start
2016-03-10
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
133; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Truvada
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE133 mg/1
TENOFOVIR DISOPROXIL FUMARATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOTT9J7900I, G70B4ETF4S
Rxcui476556, 639888, 1744001, 1744003, 1744005, 1744007, 1744009, 1744011

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0704-1Truvada30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0704-1EA - Each61958-0704ceb4ff8f-e9d0-481e-822f-6094c21ccc0512016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
emtricitabineACTIVE INGREDIENTG70B4ETF4STRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
tenofovir disoproxil fumarateACTIVE INGREDIENTOTT9J7900ITRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
emtricitabineACTIVE MOIETYG70B4ETF4STRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
tenofovir anhydrousACTIVE MOIETYW4HFE001U5TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
aluminum oxideINACTIVE INGREDIENTLMI26O6933TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
magnesium stearateINACTIVE INGREDIENT70097M6I30TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
starch, cornINACTIVE INGREDIENTO8232NY3SJTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
triacetinINACTIVE INGREDIENTXHX3C3X673TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19
waterINACTIVE INGREDIENT059QF0KO0RTRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0704TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]31Current NDC, Legacy NDC, 1 package rows20240524_54e82b13-a037-49ed-b4b3-030b37c0ecdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744003Truvada 100 MG / 150 MG Oral tabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744007Truvada 133 MG / 200 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744011Truvada 167 MG / 250 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
639888Truvada 200 MG / 300 MG Oral TabletPSN54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744003emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet [Truvada]SBD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744007emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet [Truvada]SBD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744011emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet [Truvada]SBD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
639888emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]SBD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletSCD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletSCD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletSCD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744003Truvada (emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG)) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744007Truvada (emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG)) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744011Truvada (emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG)) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
639888Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral TabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32
1744003Truvada 100 MG / 150 MG Oral tabletSY54e82b13-a037-49ed-b4b3-030b37c0ecdd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-0704-16195807040130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0704-1) 2016-03-100000-00-00NoNoCurrent