Home NDC 64380-714 TENOFOVIR DISOPROXIL FUMARATE
Product NDC 64380-714
11-digit product format 643800714
Labeler code 64380
Product ID 64380-714_762da33a-4f6e-47c9-b503-2b74bb6ddbfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tenofovir disoproxil fumarate
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA090742
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64380-714-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64380-714-04 0efc9e666f02…f202fb6c5f17…
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 64380-714-04 TENOFOVIR DISOPROXIL FUMARATE 30 in 1 BOTTLE TABLET 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-714 TENOFOVIR DISOPROXIL FUMARATE TABLET [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 1 package rows 20250129_bcd3120b-60f6-41d8-a512-ed4a62c836b4.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 64380-714-04 64380071404 30 TABLET in 1 BOTTLE (64380-714-04) 30 tablet 2018-01-26 0000-00-00 No No Current