Home NDC 0904-6821 tenofovir disoproxil fumarate
Product NDC 0904-6821
11-digit product format 009046821
Labeler code 0904
Product ID 0904-6821_cc508ae9-cfcb-48f7-b742-a0d3eec666b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA203232
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 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 A203232-001 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 A203232-001 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 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203232-001 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203232-001 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 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 0904-6821-04 tenofovir disoproxil fumarate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 0904-6821-04 tenofovir disoproxil fumarate 30 in 1 CARTON TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6821 TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20250418_da78a5d3-f5c6-47fe-b593-3252704c225d.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 0904-6821-04 00904682104 30 BLISTER PACK in 1 CARTON (0904-6821-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2018-01-26 0000-00-00 No No Current