FDA.reportPublic FDA data

TENOFOVIR DISOPROXIL FUMARATE

Product NDC
62135-466
11-digit product format
621350466
Labeler code
62135
Product ID
62135-466_ef9f6879-525d-e5a6-e053-2a95a90ad8be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TENOFOVIR DISOPROXIL FUMARATE Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA206481
Marketing category
ANDA
Marketing start
2018-07-31
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
TENOFOVIR DISOPROXIL FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOTT9J7900I
Rxcui349251

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-466-30TENOFOVIR DISOPROXIL FUMARATE30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-466-30EA - Each62135-466a10437e0-0e1d-4ea3-93fe-6db61ce55cbe12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-466TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE TABLETS) TABLET, FILM COATED [CHARTWELL RX, LLC.]2Current NDC, Legacy NDC, 1 package rows20221213_9cf11bd3-01b9-4ac8-96cc-55d57998b51d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSN9cf11bd3-01b9-4ac8-96cc-55d57998b51d2
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCD9cf11bd3-01b9-4ac8-96cc-55d57998b51d2
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY9cf11bd3-01b9-4ac8-96cc-55d57998b51d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-466-306213504663030 TABLET, FILM COATED in 1 BOTTLE (62135-466-30) 2022-06-300000-00-00NoNoCurrent