Home NDC 65862-818 Tenofovir Disoproxil Fumarate
Product NDC 65862-818
11-digit product format 658620818
Labeler code 65862
Product ID 65862-818_ab772f55-3f84-41df-a84f-3a7035602cfd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA090647
Marketing category ANDA
Marketing start 2018-01-26
Substance TENOFOVIR DISOPROXIL FUMARATE
Active strength 150 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090647-001 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 A090647-002 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 A090647-003 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 A090647-004 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090647-001 TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090647-002 TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090647-003 TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090647-004 TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 150 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349251 Internal RxNorm lookup 1243227 Internal RxNorm lookup 1243324 Internal RxNorm lookup 1243328 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 65862-818-03 Tenofovir Disoproxil Fumarate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 18 65862-818-03 Tenofovir Disoproxil Fumarate 3 in 1 CARTON TABLET, FILM COATED 3 18 65862-818-30 Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-818 TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 18 Current NDC, Legacy NDC, 3 package rows 20240608_a75c6be8-3719-4bb3-8a9e-06e5254d2a82.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 · 1 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 65862-818-03 65862081803 3 BLISTER PACK in 1 CARTON (65862-818-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2018-01-26 0000-00-00 No No Current 65862-818-30 65862081830 30 TABLET, FILM COATED in 1 BOTTLE (65862-818-30) 2018-01-26 0000-00-00 No No Current