Home NDC 71921-105 Tenofovir Disoproxil Fumarate
Product NDC 71921-105
11-digit product format 719210105
Labeler code 71921
Product ID 71921-105_79278443-b9ee-4db6-ac15-a3d12b359eb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tenofovir Disoproxil Fumarate
Dosage form TABLET, COATED
Route ORAL
Labeler Florida Pharmaceutical Products, LLC.
Application ANDA209498
Marketing category ANDA
Marketing start 2025-11-26
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209498-001 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 A209498-002 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 A209498-003 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209498-002 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209498-003 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209498-001 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-03-02 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tenofovir Disoproxil Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349251 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71921-105-33 Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tenofovir Disoproxil Fumarate TENOFOVIR DISOPROXIL FUMARATE Bryant Ranch Prepack e0ae0aa2-3baa-4b75-9e85-68b5338c3c14 2026-07-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209498 application number: ANDA209498 Tenofovir Disoproxil Fumarate TENOFOVIR DISOPROXIL FUMARATE Bryant Ranch Prepack 3285f345-e58d-4831-a6a8-31094c8c546d 2025-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209498 application number: ANDA209498 Tenofovir Disoproxil Fumarate TENOFOVIR DISOPROXIL FUMARATE Florida Pharmaceutical Products, LLC. 0c7d72d6-bf80-49e0-921c-20169e87e62f 2025-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209498 application number: ANDA209498 ndc (product): 71921-105 Tenofovir Disoproxil Fumarate TENOFOVIR DISOPROXIL FUMARATE Quinn Pharmaceuticals 92569e53-507e-7a5b-e053-2995a90aca35 2025-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209498 application number: ANDA209498
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71921-105-33 71921010533 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71921-105-33) 2025-11-26 No No Current