Home NDC 50090-5957-1 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product NDC 50090-5957
Requested package NDC 50090-5957-1
11-digit product format 500905957
Labeler code 50090
Product ID 50090-5957_f7b99260-8610-40c4-b569-82f926eb916e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA204131
Marketing category ANDA
Marketing start 2021-06-23
Marketing end 0000-00-00
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204131-001 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.
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 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204131-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2021-06-04 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5957-1 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5957 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 1 package rows 20220429_868ef2cd-57e7-43f5-8a8d-454e4d0628e5.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 Marketing start Marketing end Sample Exclude flag Status 50090-5957-1 50090595701 30 TABLET, FILM COATED in 1 BOTTLE (50090-5957-1) 2022-04-21 0000-00-00 No No Current