FDA.reportPublic FDA data

DESCOVY

Product NDC
61958-2005
11-digit product format
619582005
Labeler code
61958
Product ID
61958-2005_12aff732-63cd-4d90-a329-7c3851e6b966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir alafenamide
Dosage form
TABLET
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA208215
Marketing category
NDA
Marketing start
2022-01-07
Substance
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength
120; 15 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
DESCOVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE120 mg/1
TENOFOVIR ALAFENAMIDE FUMARATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG70B4ETF4S, FWF6Q91TZO
Rxcui1747691, 1747697, 2590641, 2590643

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-2005-12025-02-01C16284748780-1ab0e2407-33ca-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DESCOVY safely and effectively. See full prescribing information for DESCOVY. DESCOVY ® (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015
61958-2005-12025-01-30C16284748780-1ab0e2407-33ca-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DESCOVY safely and effectively. See full prescribing information for DESCOVY. DESCOVY ® (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-2005-1DESCOVY30 in 1 BOTTLE, PLASTICTABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-2005-1EA - Each61958-2005859ba9d0-41b7-483a-a3f2-95a14213146b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-2005DESCOVY (EMTRICITABINE AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]11Current NDC, Legacy NDC, 1 package rows20250202_06f66e98-e6ee-4538-9506-6c1282cc14c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590643Descovy 120 MG / 15 MG Oral TabletPSN06f66e98-e6ee-4538-9506-6c1282cc14c112
1747697Descovy 200 MG / 25 MG Oral TabletPSN06f66e98-e6ee-4538-9506-6c1282cc14c112
2590641emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral TabletPSN06f66e98-e6ee-4538-9506-6c1282cc14c112
1747691emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletPSN06f66e98-e6ee-4538-9506-6c1282cc14c112
2590643emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet [Descovy]SBD06f66e98-e6ee-4538-9506-6c1282cc14c112
1747697emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Descovy]SBD06f66e98-e6ee-4538-9506-6c1282cc14c112
2590641emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral TabletSCD06f66e98-e6ee-4538-9506-6c1282cc14c112
1747691emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletSCD06f66e98-e6ee-4538-9506-6c1282cc14c112
2590643Descovy (emtricitabine 120 MG / tenofovir alafenamide 15 MG) Oral TabletSY06f66e98-e6ee-4538-9506-6c1282cc14c112
1747697Descovy (emtricitabine 200 MG / tenofovir alafenamide 25 MG) Oral TabletSY06f66e98-e6ee-4538-9506-6c1282cc14c112
2590641emtricitabine 120 MG / tenofovir alafenamide 15 MG (as tenofovir alafenamide fumarate 16.8 MG) Oral TabletSY06f66e98-e6ee-4538-9506-6c1282cc14c112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-2005-16195820050130 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1) 30 tablet2022-01-070000-00-00NoNoCurrent