FDA.reportPublic FDA data

Tenofovir Disoproxil Fumarate

Product NDC
67184-0521
11-digit product format
671840521
Labeler code
67184
Product ID
67184-0521_ec0e46de-c8b5-371b-e053-2995a90a9f95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA209498
Marketing category
ANDA
Marketing start
2020-01-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209498-001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02
A209498-002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02
A209498-003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209498-001AB
A209498-002AB
A209498-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-002TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-03-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-003TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-03-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209498-001TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-03-028072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209498-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209498-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209498-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209498-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209498-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209498-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209498-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209498-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209498-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209498-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209498-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209498-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209498-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209498-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209498-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209498-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209498-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209498-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209498-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209498-001AB18072bd15b7f6…

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
67184-0521-1Tenofovir Disoproxil Fumarate30 in 1 BOTTLE, PLASTICTABLET, COATED3011
67184-0521-2Tenofovir Disoproxil Fumarate300 in 1 BOTTLE, PLASTICTABLET, COATED30011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0521TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED [QILU PHARMACEUTICAL CO., LTD.]11Legacy NDC, 2 package rows20221029_b43a3cae-059e-4af8-8fcf-07a597e57f0d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepacke0ae0aa2-3baa-4b75-9e85-68b5338c3c142026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209498
application number: ANDA209498
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepack3285f345-e58d-4831-a6a8-31094c8c546d2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209498
application number: ANDA209498
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEFlorida Pharmaceutical Products, LLC.0c7d72d6-bf80-49e0-921c-20169e87e62f2025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209498
application number: ANDA209498
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEQuinn Pharmaceuticals92569e53-507e-7a5b-e053-2995a90aca352025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209498
application number: ANDA209498

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243328tenofovir disoproxil fumarate 200 MG Oral TabletPSNb43a3cae-059e-4af8-8fcf-07a597e57f0d11
1243227tenofovir disoproxil fumarate 250 MG Oral TabletPSNb43a3cae-059e-4af8-8fcf-07a597e57f0d11
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNb43a3cae-059e-4af8-8fcf-07a597e57f0d11
1243328tenofovir disoproxil fumarate 200 MG Oral TabletSCDb43a3cae-059e-4af8-8fcf-07a597e57f0d11
1243227tenofovir disoproxil fumarate 250 MG Oral TabletSCDb43a3cae-059e-4af8-8fcf-07a597e57f0d11
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDb43a3cae-059e-4af8-8fcf-07a597e57f0d11
1243328tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSYb43a3cae-059e-4af8-8fcf-07a597e57f0d11
1243227tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSYb43a3cae-059e-4af8-8fcf-07a597e57f0d11
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYb43a3cae-059e-4af8-8fcf-07a597e57f0d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67184-0521-16718405210130 TABLET, COATED in 1 BOTTLE, PLASTIC (67184-0521-1) 2020-01-010000-00-00NoNoCurrent
67184-0521-267184052102300 TABLET, COATED in 1 BOTTLE, PLASTIC (67184-0521-2) 2020-01-010000-00-00NoNoCurrent