FDA.reportPublic FDA data

Tenofovir disoproxil fumarate

Product NDC
69097-533
11-digit product format
690970533
Labeler code
69097
Product ID
69097-533_cee87535-9401-4baf-920c-7184d8959c09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir disoproxil fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA078800
Marketing category
ANDA
Marketing start
2018-01-26
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
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
69097-533-02Tenofovir disoproxil fumarate30 in 1 BOTTLETABLET3010
69097-533-15Tenofovir disoproxil fumarate1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-533-02EA - Each69097-5334d757883-9bea-4644-8627-2ecfbf9a758f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-533TENOFOVIR DISOPROXIL FUMARATE TABLET [CIPLA USA INC.]10Current NDC, Legacy NDC, 2 package rows20240307_de27413a-6579-4586-80dc-39c712652952.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNde27413a-6579-4586-80dc-39c71265295210
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDde27413a-6579-4586-80dc-39c71265295210
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYde27413a-6579-4586-80dc-39c71265295210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-533-026909705330230 TABLET in 1 BOTTLE (69097-533-02) 30 tablet2018-01-260000-00-00NoNoCurrent
69097-533-15690970533151000 TABLET in 1 BOTTLE (69097-533-15) 1000 tablet2018-01-260000-00-00NoNoCurrent