Home NDC 50268-758 TENOFOVIR DISOPROXIL FUMARATE
Product NDC 50268-758
11-digit product format 502680758
Labeler code 50268
Product ID 50268-758_47fc8e5e-ba97-0118-e063-6394a90ad45c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tenofovir disoproxil fumarate
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA090742
Marketing category ANDA
Marketing start 2020-03-30
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090742-001 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090742-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090742-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TENOFOVIR DISOPROXIL FUMARATE
Listing expiration 2027-12-31 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 50268-758-11 TENOFOVIR DISOPROXIL FUMARATE 1 in 1 BLISTER PACK TABLET 1 4 50268-758-12 TENOFOVIR DISOPROXIL FUMARATE 20 in 1 BOX TABLET 20 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-758 TENOFOVIR DISOPROXIL FUMARATE TABLET [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240110_a215f64c-84de-0649-e053-2a95a90a9d59.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-758-11 50268075811 1 in 1 BLISTER PACK Historical 50268-758-12 50268075812 20 BLISTER PACK in 1 BOX (50268-758-12) / 1 TABLET in 1 BLISTER PACK (50268-758-11) 20 blister pack 2020-03-30 0000-00-00 No No Current