Home NDC 72189-312-03 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product NDC 72189-312
Requested package NDC 72189-312-03
11-digit product format 721890312
Labeler code 72189
Product ID 72189-312_2c3cf1d7-38f6-4d25-e063-6294a90aa8cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DirectRx
Application ANDA204131
Marketing category ANDA
Marketing start 2022-01-26
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-312 72189-312-03 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-312 72189-312-03 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 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# 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 72189-312-03 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 3 in 1 BOTTLE TABLET, FILM COATED 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-312 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [DIRECTRX] 2 Current NDC, Legacy NDC, 1 package rows 20250122_d67e2df4-4094-4f5a-e053-2a95a90ae4aa.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 72189-312-03 72189031203 3 TABLET, FILM COATED in 1 BOTTLE (72189-312-03) 2022-01-26 0000-00-00 No No Current