Home NDC 65862-354 Emtricitabine and Tenofovir Disoproxil Fumarate
Product NDC 65862-354
11-digit product format 658620354
Labeler code 65862
Product ID 65862-354_b37ba569-2bd3-4931-81d7-fb401180189c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA090513
Marketing category ANDA
Marketing start 2021-03-30
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200; 300 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-354 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 65862-354 65862-354-15 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 32 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 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-354-15 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-354-15 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-354-15 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-354-15 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-354-15 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-354-15 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-354-15 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-354-15 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-354-15 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-354-15 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-354-15 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-354-15 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-354-15 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-354-15 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-354-15 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-354-15 6db9cb8d1e19…3449e1ec5b70…
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 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;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 A090513-001 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 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2018-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090513-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;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 Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup 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 476556 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 65862-354-30 Emtricitabine and Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-354 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 Current NDC, Legacy NDC, 1 package rows 20240612_d8c32565-9ff2-4bfb-a5cf-ae6e0e498ccc.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Emtricitabine/TDF EMTRICITABINE/TDF Direct_Rx ef1a90ca-92bc-3787-e053-2a95a90a58ec 2025-01-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090513 application number: ANDA090513 Emtricitabine and Tenofovir Disoproxil Fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Proficient Rx LP d3b849a7-219d-4acc-9e29-8f246cb4a7a9 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090513 application number: ANDA090513 Emtricitabine and Tenofovir Disoproxil Fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE QUALLENT PHARMACEUTICALS HEALTH LLC 4af2529d-a14f-4337-87ed-04f8f27da746 2024-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090513 application number: ANDA090513 Emtricitabine and Tenofovir Disoproxil Fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Aurobindo Pharma Limited d8c32565-9ff2-4bfb-a5cf-ae6e0e498ccc 2024-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090513 application number: ANDA090513 ndc (product): 65862-354
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65862-354-15 65862035415 1500 TABLET, FILM COATED in 1 BAG (65862-354-15) 30-MAR-21 Current 65862-354-30 65862035430 30 TABLET, FILM COATED in 1 BOTTLE (65862-354-30) 2021-03-30 0000-00-00 No No Current