Home NDC 61958-2204 Epclusa
Product NDC 61958-2204
11-digit product format 619582204
Labeler code 61958
Product ID 61958-2204_4e28b652-df20-450d-9f6e-4cc6e355e223
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Velpatasvir and Sofosbuvir
Dosage form PELLET
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA214187
Marketing category NDA
Marketing start 2021-06-10
Substance SOFOSBUVIR; VELPATASVIR
Active strength 200; 50 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 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 N214187-001 EPCLUSA SOFOSBUVIR; VELPATASVIR 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 N214187-002 EPCLUSA SOFOSBUVIR; VELPATASVIR 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10
Orange Book patents# Current patent rows page 1 of 1 · 56 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214187-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8735372 2028-03-21 U-1470 2021-06-29 N214187-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8334270*PED 2028-09-21 Pediatric extension N214187-001 8580765*PED 2028-09-21 Pediatric extension N214187-001 8735372*PED 2028-09-21 Pediatric extension N214187-001 9085573*PED 2028-09-21 Pediatric extension N214187-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8889159 2029-03-26 U-1470 Drug product 2021-06-29 N214187-001 7964580*PED 2029-09-26 Pediatric extension N214187-001 8633309*PED 2029-09-26 Pediatric extension N214187-001 8889159*PED 2029-09-26 Pediatric extension N214187-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 9284342*PED 2031-03-13 Pediatric extension N214187-001 8618076*PED 2031-06-11 Pediatric extension N214187-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-001 8575135*PED 2033-05-16 Pediatric extension N214187-001 8921341*PED 2033-05-16 Pediatric extension N214187-001 8940718*PED 2033-05-16 Pediatric extension N214187-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N214187-001 11707479 2034-01-30 U-1470 Drug product 2023-08-15 N214187-001 11116783*PED 2034-07-30 Pediatric extension N214187-001 11707479*PED 2034-07-30 Pediatric extension N214187-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8735372 2028-03-21 U-1470 2021-06-29 N214187-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8334270*PED 2028-09-21 Pediatric extension N214187-002 8580765*PED 2028-09-21 Pediatric extension N214187-002 8735372*PED 2028-09-21 Pediatric extension N214187-002 9085573*PED 2028-09-21 Pediatric extension N214187-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8889159 2029-03-26 U-1470 Drug product 2021-06-29 N214187-002 7964580*PED 2029-09-26 Pediatric extension N214187-002 8633309*PED 2029-09-26 Pediatric extension N214187-002 8889159*PED 2029-09-26 Pediatric extension N214187-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 9284342*PED 2031-03-13 Pediatric extension N214187-002 8618076*PED 2031-06-11 Pediatric extension N214187-002 8575135 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8921341 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8940718 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 N214187-002 8575135*PED 2033-05-16 Pediatric extension N214187-002 8921341*PED 2033-05-16 Pediatric extension N214187-002 8940718*PED 2033-05-16 Pediatric extension N214187-002 11116783 2034-01-30 U-1470 Drug product 2021-10-01 N214187-002 11707479 2034-01-30 U-1470 Drug product 2023-08-15 N214187-002 11116783*PED 2034-07-30 Pediatric extension N214187-002 11707479*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 · 66 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 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214187-001 EPCLUSA 150MG;37.5MG/PACKET PELLETS / ORAL RLD 2021-06-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214187-002 EPCLUSA 200MG;50MG/PACKET PELLETS / ORAL RLD, RS 2021-06-10 6a51e52b5d6a…
Observed Orange Book patent history# Patent history page 1 of 45 · 1,796 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 N214187-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8735372 2028-03-21 U-1470 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8889159 2029-03-26 U-1470 Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8575135 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8921341 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8940718 2032-11-16 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8575135*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8921341*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 8940718*PED 2033-05-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 11116783 2034-01-30 U-1470 Drug product 2021-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 11707479 2034-01-30 U-1470 Drug product 2023-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 11116783*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-001 11707479*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8735372 2028-03-21 U-1470 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 8889159 2029-03-26 U-1470 Drug product 2021-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214187-002 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 176 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Epclusa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VELPATASVIR 200 mg/1 SOFOSBUVIR 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WJ6CA3ZU8B Internal UNII lookup KCU0C7RS7Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1799212 Internal RxNorm lookup 1799218 Internal RxNorm lookup 2288814 Internal RxNorm lookup 2288816 Internal RxNorm lookup 2584196 Internal RxNorm lookup 2584199 Internal RxNorm lookup 2584200 Internal RxNorm lookup 2584201 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 61958-2204-1 Epclusa 28 in 1 CARTON PELLET 28 14 61958-2204-1 Epclusa 1 in 1 PACKET PELLET 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-2204 EPCLUSA (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED EPCLUSA (VELPATASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20250206_7f30631a-ee3b-4cfe-866b-964df3f0a44f.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 Epclusa VELPATASVIR AND SOFOSBUVIR Gilead Sciences, Inc. 7f30631a-ee3b-4cfe-866b-964df3f0a44f 2024-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214187 application number: NDA214187 ndc (product): 61958-2204
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 61958-2204-1 61958220401 28 PACKET in 1 CARTON (61958-2204-1) / 1 PELLET in 1 PACKET 28 packet 2021-06-10 0000-00-00 No No Current