FDA.reportPublic FDA data

Viread

Product NDC
61958-0401
11-digit product format
619580401
Labeler code
61958
Product ID
61958-0401_1b2267fa-9978-4429-ac13-09a5d43b3093
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA021356
Marketing category
NDA
Marketing start
2001-10-26
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 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
Viread
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOTT9J7900I
Rxcui349251, 352050, 1243227, 1243229, 1243324, 1243326, 1243328, 1243330, 1243343, 1243346

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
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0401-12025-02-20C16284748780-12cef2736-ab35-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. VIREAD ® (tenofovir disoproxil fumarate) tablets, for oral use VIREAD ® (tenofovir disoproxil fumarate) powder, for oral use Initial U.S. Approval: 2001
61958-0401-12025-01-30C16284748780-12cef2736-ab35-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. VIREAD ® (tenofovir disoproxil fumarate) tablets, for oral use VIREAD ® (tenofovir disoproxil fumarate) powder, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0401-1Viread30 in 1 BOTTLE, PLASTICTABLET, COATED3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0401-1EA - Each61958-040159b65336-9b7b-42fb-a051-bf2e2fa4ab7a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900IVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
MANNITOLINACTIVE INGREDIENT3OWL53L36AVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
TRIACETININACTIVE INGREDIENTXHX3C3X673VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]22
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
61958-0401VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.]31Current NDC, Legacy NDC, 1 package rows20250223_33fd6418-fbdc-42ca-a50d-ce2a476a5418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243324tenofovir disoproxil fumarate 150 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243328tenofovir disoproxil fumarate 200 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243227tenofovir disoproxil fumarate 250 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243343tenofovir disoproxil fumarate 40 MG/GM Oral PowderPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243326Viread 150 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243330Viread 200 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243229Viread 250 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
352050Viread 300 MG Oral TabletPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243346Viread 40 MG/GM Oral PowderPSN33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243346tenofovir disoproxil fumarate 0.04 MG/MG Oral Powder [Viread]SBD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243326tenofovir disoproxil fumarate 150 MG Oral Tablet [Viread]SBD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243330tenofovir disoproxil fumarate 200 MG Oral Tablet [Viread]SBD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243229tenofovir disoproxil fumarate 250 MG Oral Tablet [Viread]SBD33fd6418-fbdc-42ca-a50d-ce2a476a541831
352050tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]SBD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243343tenofovir disoproxil fumarate 0.04 MG/MG Oral PowderSCD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243324tenofovir disoproxil fumarate 150 MG Oral TabletSCD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243328tenofovir disoproxil fumarate 200 MG Oral TabletSCD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243227tenofovir disoproxil fumarate 250 MG Oral TabletSCD33fd6418-fbdc-42ca-a50d-ce2a476a541831
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCD33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243324tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243328tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243227tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243343tenofovir disoproxil fumarate 40 MG (equivalent to tenofovir disoproxil 33 MG) per GM Oral PowderSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243343tenofovir disoproxil fumarate 40 MG per GM Oral PowderSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243346Viread 0.04 MG/MG Oral PowderSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243326Viread 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243326Viread 150 MG Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243330Viread 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243330Viread 200 MG Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243229Viread 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243229Viread 250 MG Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
352050Viread 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
352050Viread 300 MG Oral TabletSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243346Viread 40 MG (equivalent to tenofovir disoproxil 33 MG) per GM Oral PowderSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
1243346Viread 40 MG per GM Oral PowderSY33fd6418-fbdc-42ca-a50d-ce2a476a541831
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNd3d0b5ef-8226-49d6-ab66-987943413ccc1
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNe122435e-cd0b-4c90-940a-b7a0d090d8661
352050Viread 300 MG Oral TabletPSNd3d0b5ef-8226-49d6-ab66-987943413ccc1
352050Viread 300 MG Oral TabletPSNe122435e-cd0b-4c90-940a-b7a0d090d8661
352050tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]SBDd3d0b5ef-8226-49d6-ab66-987943413ccc1
352050tenofovir disoproxil fumarate 300 MG Oral Tablet [Viread]SBDe122435e-cd0b-4c90-940a-b7a0d090d8661
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDd3d0b5ef-8226-49d6-ab66-987943413ccc1
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDe122435e-cd0b-4c90-940a-b7a0d090d8661
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYd3d0b5ef-8226-49d6-ab66-987943413ccc1
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 (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYd3d0b5ef-8226-49d6-ab66-987943413ccc1
352050Viread 300 MG Oral TabletSYe122435e-cd0b-4c90-940a-b7a0d090d8661
352050Viread 300 MG Oral TabletSYd3d0b5ef-8226-49d6-ab66-987943413ccc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-0401-16195804010130 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1) 2001-10-260000-00-00NoNoCurrent