Home NDC 72626-2601 Ledipasvir and Sofosbuvir
Product NDC 72626-2601
11-digit product format 726262601
Labeler code 72626
Product ID 72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ledipasvir and Sofosbuvir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asegua Therapeutics LLC
Application NDA205834
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-01-01
Substance LEDIPASVIR; SOFOSBUVIR
Active strength 90; 400 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], 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72626-2601 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72626-2601 72626-2601-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 N205834-001 HARVONI LEDIPASVIR; SOFOSBUVIR 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 N205834-002 HARVONI LEDIPASVIR; SOFOSBUVIR 45MG;200MG TABLET / ORAL RLD 2019-08-28
Orange Book patents# Current patent rows page 1 of 1 · 67 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205834-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 8735372 2028-03-21 U-1470 2014-10-30 N205834-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2015-08-11 N205834-001 8334270*PED 2028-09-21 Pediatric extension N205834-001 8580765*PED 2028-09-21 Pediatric extension N205834-001 8735372*PED 2028-09-21 Pediatric extension N205834-001 9085573*PED 2028-09-21 Pediatric extension N205834-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 8889159 2029-03-26 U-1470 Drug product 2014-12-11 N205834-001 7964580*PED 2029-09-26 Pediatric extension N205834-001 8633309*PED 2029-09-26 Pediatric extension N205834-001 8889159*PED 2029-09-26 Pediatric extension N205834-001 8088368 2030-05-12 Drug substance, Drug product 2014-10-30 N205834-001 8273341 2030-05-12 U-1470 2014-10-30 N205834-001 8822430 2030-05-12 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 8841278 2030-05-12 U-1470 Drug product 2014-10-30 N205834-001 9511056 2030-05-12 U-1470 Drug product 2017-01-05 N205834-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-04-12 N205834-001 8088368*PED 2030-11-12 Pediatric extension N205834-001 8273341*PED 2030-11-12 Pediatric extension N205834-001 8822430*PED 2030-11-12 Pediatric extension N205834-001 8841278*PED 2030-11-12 Pediatric extension N205834-001 9511056*PED 2030-11-12 Pediatric extension N205834-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2014-10-30 N205834-001 9284342*PED 2031-03-13 Pediatric extension N205834-001 8618076*PED 2031-06-11 Pediatric extension N205834-001 10456414 2032-09-14 Drug product 2019-11-20 N205834-001 9393256 2032-09-14 U-1470 2016-08-15 N205834-001 9393256*PED 2033-03-14 Pediatric extension N205834-001 10039779 2034-01-30 U-2369 Drug substance, Drug product 2018-08-29 N205834-001 10039779 2034-01-30 U-2370 Drug substance, Drug product 2018-08-29 N205834-001 10039779*PED 2034-07-30 Pediatric extension N205834-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8735372 2028-03-21 U-1470 2019-09-23 N205834-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8334270*PED 2028-09-21 Pediatric extension N205834-002 8580765*PED 2028-09-21 Pediatric extension N205834-002 8735372*PED 2028-09-21 Pediatric extension N205834-002 9085573*PED 2028-09-21 Pediatric extension N205834-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8889159 2029-03-26 U-1470 Drug product 2019-09-23 N205834-002 7964580*PED 2029-09-26 Pediatric extension N205834-002 8633309*PED 2029-09-26 Pediatric extension N205834-002 8889159*PED 2029-09-26 Pediatric extension N205834-002 8088368 2030-05-12 Drug substance, Drug product 2019-09-23 N205834-002 8273341 2030-05-12 U-1470 2019-09-23 N205834-002 8822430 2030-05-12 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8841278 2030-05-12 U-1470 Drug product 2019-09-23 N205834-002 9511056 2030-05-12 U-1470 2019-09-23 N205834-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 8088368*PED 2030-11-12 Pediatric extension N205834-002 8273341*PED 2030-11-12 Pediatric extension N205834-002 8822430*PED 2030-11-12 Pediatric extension N205834-002 8841278*PED 2030-11-12 Pediatric extension N205834-002 9511056*PED 2030-11-12 Pediatric extension N205834-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 9284342*PED 2031-03-13 Pediatric extension N205834-002 8618076*PED 2031-06-11 Pediatric extension N205834-002 10456414 2032-09-14 Drug product 2019-11-20 N205834-002 9393256 2032-09-14 U-1470 2019-09-23 N205834-002 9393256*PED 2033-03-14 Pediatric extension N205834-002 10039779 2034-01-30 U-1470 Drug substance, Drug product 2019-09-23 N205834-002 10039779*PED 2034-07-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205834-001 ODE* 2026-08-28 N205834-002 ODE* 2026-08-28
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 3 · 81 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 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205834-001 HARVONI 90MG;400MG TABLET / ORAL RLD, RS 2014-10-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205834-002 HARVONI 45MG;200MG TABLET / ORAL RLD 2019-08-28 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 67 · 2,661 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 N205834-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8735372 2028-03-21 U-1470 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2015-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8735372*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8889159 2029-03-26 U-1470 Drug product 2014-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8088368 2030-05-12 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8273341 2030-05-12 U-1470 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8822430 2030-05-12 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8841278 2030-05-12 U-1470 Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9511056 2030-05-12 U-1470 Drug product 2017-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2016-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8088368*PED 2030-11-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8273341*PED 2030-11-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8822430*PED 2030-11-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8841278*PED 2030-11-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9511056*PED 2030-11-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 10456414 2032-09-14 Drug product 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9393256 2032-09-14 U-1470 2016-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 9393256*PED 2033-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 10039779 2034-01-30 U-2369 Drug substance, Drug product 2018-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 10039779 2034-01-30 U-2370 Drug substance, Drug product 2018-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-001 10039779*PED 2034-07-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 8735372 2028-03-21 U-1470 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205834-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 279 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ledipasvir and Sofosbuvir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEDIPASVIR 90 mg/1 SOFOSBUVIR 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 013TE6E4WV 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 1591943 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 72626-2601-1 Ledipasvir and Sofosbuvir 14 in 1 BLISTER PACK TABLET, FILM COATED 14 8 72626-2601-1 Ledipasvir and Sofosbuvir 2 in 1 CARTON TABLET, FILM COATED 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72626-2601 LEDIPASVIR AND SOFOSBUVIR TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250119_46f4a73b-0cd6-4902-9092-3ac79e882c1a.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 72626-2601-1 72626260101 2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-01-01 0000-00-00 No No Current