Home NDC 61958-2101 ODEFSEY
Product NDC 61958-2101
11-digit product format 619582101
Labeler code 61958
Product ID 61958-2101_130b8bbc-f660-40ff-831c-139734f90b99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
Dosage form TABLET
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA208351
Marketing category NDA
Marketing start 2016-03-01
Substance EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength 200; 25; 25 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], 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 · 6 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61958-2101-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61958-2101-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61958-2101-1 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 N208351-001 ODEFSEY EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-03-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208351-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 N208351-001 8754065*PED 2033-02-15 Pediatric extension N208351-001 9296769*PED 2033-02-15 Pediatric extension
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 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208351-001 ODEFSEY 200MG;EQ 25MG BASE;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-03-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208351-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208351-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 363 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208351-001 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208351-001 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 7390791 2025-01-07 Drug substance, Drug product 2016-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2016-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208351-001 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208351-001 7390791 2025-01-07 Drug substance, Drug product 2016-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2016-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 7390791*PED 2025-07-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 8754065*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208351-001 9296769*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 7390791 2025-01-07 Drug substance, Drug product 2016-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2016-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 7390791*PED 2025-07-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 8754065*PED 2033-02-15 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208351-001 9296769*PED 2033-02-15 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 7390791 2025-01-07 Drug substance, Drug product 2016-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2016-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 7390791*PED 2025-07-07 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 8754065*PED 2033-02-15 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208351-001 9296769*PED 2033-02-15 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 7390791 2025-04-17 Drug substance, Drug product 2016-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2016-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 7390791*PED 2025-10-17 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 8754065*PED 2033-02-15 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208351-001 9296769*PED 2033-02-15 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208351-001 7390791 2025-04-17 Drug substance, Drug product 2016-03-24 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ODEFSEY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 RILPIVIRINE HYDROCHLORIDE 25 mg/1 TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup 212WAX8KDD Internal UNII lookup FWF6Q91TZO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1741733 Internal RxNorm lookup 1741739 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-02-11 These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 2025-01-30 These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 2023-02-06 These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 2023-01-30 These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016 2020-07-22 These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-2101-1 ODEFSEY 30 in 1 BOTTLE, PLASTIC TABLET 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-2101 ODEFSEY (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20250306_ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ODEFSEY EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE Gilead Sciences, Inc. ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5 2025-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208351 application number: NDA208351 ndc (product): 61958-2101
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 61958-2101-1 61958210101 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1) 30 tablet 2016-03-01 0000-00-00 No No Current