FDA.reportPublic FDA data

Viread

Product NDC
53808-0810
11-digit product format
538080810
Labeler code
53808
Product ID
53808-0810_bea0f43d-4f45-40d2-b4a4-3ac996bb1626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tenofovir disoproxil fumarate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021356
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
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
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0810-12020-01-31C16284748780-19d75b9d0-2a88-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. VIREAD (tenofovir disoproxil fumarate) tablet, coated for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0810-1Viread30 in 1 BLISTER PACKTABLET, COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900IVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
tenofovirACTIVE MOIETY99YXE507ILVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0810VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100415_e122435e-cd0b-4c90-940a-b7a0d090d866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNe122435e-cd0b-4c90-940a-b7a0d090d8661
352050Viread 300 MG Oral TabletPSNe122435e-cd0b-4c90-940a-b7a0d090d8661
352050tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]SBDe122435e-cd0b-4c90-940a-b7a0d090d8661
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDe122435e-cd0b-4c90-940a-b7a0d090d8661
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYe122435e-cd0b-4c90-940a-b7a0d090d8661
352050Viread 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYe122435e-cd0b-4c90-940a-b7a0d090d8661
352050Viread 300 MG Oral TabletSYe122435e-cd0b-4c90-940a-b7a0d090d8661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0810-15380808100130 in 1 BLISTER PACKHistorical