Home NDC 72626-2701 Sofosbuvir and Velpatasvir
Product NDC 72626-2701
11-digit product format 726262701
Labeler code 72626
Product ID 72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Velpatasvir and Sofosbuvir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asegua Therapeutics LLC
Application NDA208341
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-11-14
Substance SOFOSBUVIR; VELPATASVIR
Active strength 400; 100 mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA]
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 72626-2701-1 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 72626-2701-1 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 72626-2701-1 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 N208341-001 EPCLUSA SOFOSBUVIR; VELPATASVIR 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 N208341-002 EPCLUSA SOFOSBUVIR; VELPATASVIR 200MG;50MG TABLET / ORAL RLD 2020-03-19
Orange Book patents# Current patent rows page 1 of 1 · 60 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208341-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8735372 2028-03-21 U-1470 2016-07-15 N208341-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8334270*PED 2028-09-21 Pediatric extension N208341-001 8580765*PED 2028-09-21 Pediatric extension N208341-001 8735372*PED 2028-09-21 Pediatric extension N208341-001 9085573*PED 2028-09-21 Pediatric extension N208341-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8889159 2029-03-26 U-1470 Drug product 2016-07-15 N208341-001 7964580*PED 2029-09-26 Pediatric extension N208341-001 8633309*PED 2029-09-26 Pediatric extension N208341-001 8889159*PED 2029-09-26 Pediatric extension N208341-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 9284342*PED 2031-03-13 Pediatric extension N208341-001 8618076*PED 2031-06-11 Pediatric extension N208341-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 N208341-001 8575135*PED 2033-05-16 Pediatric extension N208341-001 8921341*PED 2033-05-16 Pediatric extension N208341-001 8940718*PED 2033-05-16 Pediatric extension N208341-001 10086011 2034-01-30 U-1470 2018-10-23 N208341-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N208341-001 9757406 2034-01-30 Drug product 2017-09-26 N208341-001 10086011*PED 2034-07-30 Pediatric extension N208341-001 11116783*PED 2034-07-30 Pediatric extension N208341-001 9757406*PED 2034-07-30 Pediatric extension N208341-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8735372 2028-03-21 U-1470 2020-04-16 N208341-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8334270*PED 2028-09-21 Pediatric extension N208341-002 8580765*PED 2028-09-21 Pediatric extension N208341-002 8735372*PED 2028-09-21 Pediatric extension N208341-002 9085573*PED 2028-09-21 Pediatric extension N208341-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8889159 2029-03-26 U-1470 Drug product 2020-04-16 N208341-002 7964580*PED 2029-09-26 Pediatric extension N208341-002 8633309*PED 2029-09-26 Pediatric extension N208341-002 8889159*PED 2029-09-26 Pediatric extension N208341-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 9284342*PED 2031-03-13 Pediatric extension N208341-002 8618076*PED 2031-06-11 Pediatric extension N208341-002 8575135 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8921341 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8940718 2032-11-16 U-1470 Drug substance, Drug product 2020-04-16 N208341-002 8575135*PED 2033-05-16 Pediatric extension N208341-002 8921341*PED 2033-05-16 Pediatric extension N208341-002 8940718*PED 2033-05-16 Pediatric extension N208341-002 10086011 2034-01-30 U-1470 2020-04-16 N208341-002 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N208341-002 9757406 2034-01-30 Drug product 2020-04-16 N208341-002 10086011*PED 2034-07-30 Pediatric extension N208341-002 11116783*PED 2034-07-30 Pediatric extension N208341-002 9757406*PED 2034-07-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 · 78 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 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208341-002 EPCLUSA 200MG;50MG TABLET / ORAL RLD 2020-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208341-001 EPCLUSA 400MG;100MG TABLET / ORAL RLD, RS 2016-06-28 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 56 · 2,204 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 N208341-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8735372 2028-03-21 U-1470 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8889159 2029-03-26 U-1470 Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2016-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8575135*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8921341*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 8940718*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 10086011 2034-01-30 U-1470 2018-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9757406 2034-01-30 Drug product 2017-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 10086011*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 11116783*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-001 9757406*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8735372 2028-03-21 U-1470 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208341-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2020-04-16 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 531 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sofosbuvir and Velpatasvir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VELPATASVIR 400 mg/1 SOFOSBUVIR 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KCU0C7RS7Z Internal UNII lookup WJ6CA3ZU8B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1799212 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 72626-2701-1 Sofosbuvir and Velpatasvir 2 in 1 CARTON TABLET, FILM COATED 2 9 72626-2701-1 Sofosbuvir and Velpatasvir 14 in 1 BLISTER PACK TABLET, FILM COATED 14 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72626-2701 SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250309_d0c1a945-4440-4b5c-81aa-693ed3db597c.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 Units Marketing start Marketing end Sample Exclude flag Status 72626-2701-1 72626270101 2 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2018-11-14 0000-00-00 No No Current