Home NDC 61958-2005 DESCOVY
Product NDC 61958-2005
11-digit product format 619582005
Labeler code 61958
Product ID 61958-2005_12aff732-63cd-4d90-a329-7c3851e6b966
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine and tenofovir alafenamide
Dosage form TABLET
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA208215
Marketing category NDA
Marketing start 2022-01-07
Substance EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength 120; 15 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 · 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 61958-2005-1 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 61958-2005-1 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 61958-2005-1 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208215-001 DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 N208215-002 DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208215-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208215-001 8754065 2032-08-15 U-1259 Drug substance, Drug product 2016-05-02 N208215-001 8754065 2032-08-15 U-1663 Drug substance, Drug product 2016-05-02 N208215-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-05-02 N208215-001 9296769 2032-08-15 U-1259 Drug substance, Drug product 2016-04-26 N208215-001 9296769 2032-08-15 U-1663 Drug substance, Drug product 2016-04-26 N208215-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-26 N208215-001 8754065*PED 2033-02-15 Pediatric extension N208215-001 9296769*PED 2033-02-15 Pediatric extension N208215-001 12629338 2036-06-29 Drug product 2026-05-19 N208215-001 12648911 2036-06-29 U-1259 2026-06-09 N208215-001 12648911 2036-06-29 U-1663 2026-06-09 N208215-001 12661323 2036-06-29 Drug product 2026-06-23 N208215-002 8754065 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 N208215-002 9296769 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 N208215-002 8754065*PED 2033-02-15 Pediatric extension N208215-002 9296769*PED 2033-02-15 Pediatric extension N208215-002 12661323 2036-06-29 Drug product 2026-06-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208215-001 M-316 2028-06-20 N208215-002 M-316 2028-06-20 N208215-002 ODE-457 2029-01-07
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 · 73 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 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL AB RLD 2022-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL AB RLD 2022-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL AB RLD 2022-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-04-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL AB RLD 2022-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208215-002 DESCOVY 120MG;EQ 15MG BASE TABLET / ORAL RLD 2022-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208215-001 DESCOVY 200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2016-04-04 5aa47cf7b7d7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 16 · 602 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 N208215-001 8754065 2032-08-15 U-1259 Drug substance, Drug product 2016-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 8754065 2032-08-15 U-1663 Drug substance, Drug product 2016-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 9296769 2032-08-15 U-1259 Drug substance, Drug product 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 9296769 2032-08-15 U-1663 Drug substance, Drug product 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-001 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-002 8754065 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-002 9296769 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-002 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208215-002 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 7390791 2025-01-07 Drug substance, Drug product 2016-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 8754065 2032-08-15 U-1259 Drug substance, Drug product 2016-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 8754065 2032-08-15 U-1663 Drug substance, Drug product 2016-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 9296769 2032-08-15 U-1259 Drug substance, Drug product 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 9296769 2032-08-15 U-1663 Drug substance, Drug product 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-001 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 7390791 2025-01-07 Drug substance, Drug product 2022-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 8754065 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 9296769 2032-08-15 U-1663 Drug substance, Drug product 2022-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208215-002 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208215-001 7390791 2025-01-07 Drug substance, Drug product 2016-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 7390791*PED 2025-07-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 8754065 2032-08-15 U-1259 Drug substance, Drug product 2016-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 8754065 2032-08-15 U-1663 Drug substance, Drug product 2016-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2016-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 9296769 2032-08-15 U-1259 Drug substance, Drug product 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 9296769 2032-08-15 U-1663 Drug substance, Drug product 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 8754065*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-001 9296769*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-002 7390791 2025-01-07 Drug substance, Drug product 2022-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208215-002 7390791*PED 2025-07-07 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 113 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DESCOVY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 120 mg/1 TENOFOVIR ALAFENAMIDE FUMARATE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FWF6Q91TZO Internal UNII lookup G70B4ETF4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1747691 Internal RxNorm lookup 1747697 Internal RxNorm lookup 2590641 Internal RxNorm lookup 2590643 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-2005-1 DESCOVY 30 in 1 BOTTLE, PLASTIC TABLET 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-2005 DESCOVY (EMTRICITABINE AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20250202_06f66e98-e6ee-4538-9506-6c1282cc14c1.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 DESCOVY EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Gilead Sciences, Inc. 06f66e98-e6ee-4538-9506-6c1282cc14c1 2026-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208215 application number: NDA208215 ndc (product): 61958-2005
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 61958-2005-1 61958200501 30 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1) 30 tablet 2022-01-07 0000-00-00 No No Current