VEMLIDY

Product NDC
61958-2301
11-digit product format
619582301
Labeler code
61958
Product ID
61958-2301_175f5d1a-aae9-43d5-b004-65eefec167d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenofovir alafenamide
Dosage form
TABLET
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA208464
Marketing category
NDA
Marketing start
2016-11-10
Substance
TENOFOVIR ALAFENAMIDE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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
VEMLIDY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR ALAFENAMIDE FUMARATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFWF6Q91TZO
Rxcui1858261, 1858267

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
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-2301-1VEMLIDY30 in 1 BOTTLE, PLASTICTABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-2301-1EA - Each61958-2301919811d3-cde3-46d3-94f9-1e1ae9f2d29912016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-2301VEMLIDY (TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]16Current NDC, Legacy NDC, 1 package rows20240412_72e6b33c-0351-4070-9172-eeaa186c01d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1858261tenofovir alafenamide 25 MG Oral TabletPSN72e6b33c-0351-4070-9172-eeaa186c01d217
1858267Vemlidy 25 MG Oral TabletPSN72e6b33c-0351-4070-9172-eeaa186c01d217
1858267tenofovir alafenamide 25 MG Oral Tablet [Vemlidy]SBD72e6b33c-0351-4070-9172-eeaa186c01d217
1858261tenofovir alafenamide 25 MG Oral TabletSCD72e6b33c-0351-4070-9172-eeaa186c01d217
1858261tenofovir alafenamide 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral TabletSY72e6b33c-0351-4070-9172-eeaa186c01d217
1858267Vemlidy 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral TabletSY72e6b33c-0351-4070-9172-eeaa186c01d217
1858267Vemlidy 25 MG Oral TabletSY72e6b33c-0351-4070-9172-eeaa186c01d217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-2301-16195823010130 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1) 30 tablet2016-11-100000-00-00NoNoCurrent