FDA.reportPublic FDA data

Biktarvy

Product NDC
61958-2501
11-digit product format
619582501
Labeler code
61958
Product ID
61958-2501_245103e5-132e-4695-9b7d-bda2f2830ec3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA210251
Marketing category
NDA
Marketing start
2018-02-07
Substance
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength
50; 200; 25 mg/1; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biktarvy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BICTEGRAVIR SODIUM50 mg/1
EMTRICITABINE200 mg/1
TENOFOVIR ALAFENAMIDE FUMARATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFWF6Q91TZO, G70B4ETF4S, 4L5MP1Y7W7
Rxcui1999667, 1999673, 2584354, 2584356

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
61958-2501-12020-07-22C16284748780-1ab0e2407-2fab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
61958-2501-12020-07-22C16284748780-1ab0e2407-2fab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
61958-2501-22020-07-22C16284748780-1ab0e2407-2fab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
61958-2501-22020-07-22C16284748780-1ab0e2407-2fab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-2501-1Biktarvy30 in 1 BOTTLE, PLASTICTABLET3024
61958-2501-2Biktarvy7 in 1 BOTTLE, PLASTICTABLET724
61958-2501-3Biktarvy30 in 1 BLISTER PACKTABLET3024
61958-2501-5Biktarvy30 in 1 BLISTER PACKTABLET3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-2501-1EA - Each61958-25016aa39ee3-3afc-4ca2-b2e0-a3fdd44e9b2212018-03-08
61958-2501-3EA - Each61958-25013e8532ff-f9f4-48b0-b2b2-8bb1eece913a12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-2501BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]20Current NDC, Legacy NDC, 4 package rows20241024_664cb8f0-1f65-441b-b0d9-ba3d798be309.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584354bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral TabletPSN664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999667bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletPSN664cb8f0-1f65-441b-b0d9-ba3d798be30924
2584356Biktarvy 30 MG / 120 MG / 15 MG Oral TabletPSN664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999673Biktarvy 50 MG / 200 MG / 25 MG Oral TabletPSN664cb8f0-1f65-441b-b0d9-ba3d798be30924
2584356bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet [Biktarvy]SBD664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999673bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]SBD664cb8f0-1f65-441b-b0d9-ba3d798be30924
2584354bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral TabletSCD664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999667bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletSCD664cb8f0-1f65-441b-b0d9-ba3d798be30924
2584354bictegravir 30 MG (as bictegravir sodium 31.5 MG) / emtricitabine 120 MG / tenofovir alafenamide 15 MG (as tenofovir alafenamide fumarate 16.5 MG) Oral TabletSY664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999667bictegravir 50 MG (as bictegravir sodium 52.5 MG) / emtricitabine 200 MG / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral TabletSY664cb8f0-1f65-441b-b0d9-ba3d798be30924
2584356Biktarvy 30 MG / 120 MG / 15 MG Oral TabletSY664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999673Biktarvy 50 MG / 200 MG / 25 MG Oral TabletSY664cb8f0-1f65-441b-b0d9-ba3d798be30924
1999667bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletPSN0476d7eb-1024-4821-bbe7-abaacfda32a25
1999673Biktarvy 50 MG / 200 MG / 25 MG Oral TabletPSN0476d7eb-1024-4821-bbe7-abaacfda32a25
1999673bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]SBD0476d7eb-1024-4821-bbe7-abaacfda32a25
1999667bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral TabletSCD0476d7eb-1024-4821-bbe7-abaacfda32a25
1999667bictegravir 50 MG (as bictegravir sodium 52.5 MG) / emtricitabine 200 MG / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral TabletSY0476d7eb-1024-4821-bbe7-abaacfda32a25
1999673Biktarvy 50 MG / 200 MG / 25 MG Oral TabletSY0476d7eb-1024-4821-bbe7-abaacfda32a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-2501-16195825010130 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1) 30 tablet2018-02-070000-00-00NoNoCurrent
61958-2501-2619582501027 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2) 7 tablet2018-07-260000-00-00NoNoCurrent
61958-2501-36195825010330 TABLET in 1 BLISTER PACK (61958-2501-3) 30 tablet2021-08-240000-00-00NoNoCurrent
61958-2501-56195825010530 TABLET in 1 BLISTER PACK (61958-2501-5) 30 tablet2026-03-30NoNoCurrent