Home NDC 67296-1433 Emtricitabine and Tenofovir Disoproxil Fumarate
Product NDC 67296-1433
11-digit product format 672961433
Labeler code 67296
Product ID 67296-1433_c0aa7cb1-ae21-2cbc-e053-2995a90a3284
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA090894
Marketing category ANDA
Marketing start 2021-04-01
Marketing end 0000-00-00
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200 mg/1; mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 8 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-1433-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-1433-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-1433-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-1433-3 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090894-001 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 · 43 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 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090894-001 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB 2017-06-08 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 67296-1433-3 Emtricitabine and Tenofovir Disoproxil Fumarate 3 in 1 BOTTLE TABLET, FILM COATED 3 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1433 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [REDPHARM DRUG, INC.] 6 Legacy NDC, 1 package rows 20240808_c0aa7cb1-ae20-2cbc-e053-2995a90a3284.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 67296-1433-3 67296143303 3 TABLET, FILM COATED in 1 BOTTLE (67296-1433-3) 2021-04-01 0000-00-00 No No Current