Home NDC 61958-1505 Sovaldi
Product NDC 61958-1505
11-digit product format 619581505
Labeler code 61958
Product ID 61958-1505_74c52ec6-8358-4e63-b299-64ec1ff7f434
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SOFOSBUVIR
Dosage form PELLET
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA212480
Marketing category NDA
Marketing start 2019-08-28
Substance SOFOSBUVIR
Active strength 200 mg/1
Pharmacologic classes Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], 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 N212480-001 SOVALDI SOFOSBUVIR 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 N212480-002 SOVALDI SOFOSBUVIR 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28
Orange Book patents# Current patent rows page 1 of 1 · 32 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212480-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 8334270*PED 2028-09-21 Pediatric extension N212480-001 8580765*PED 2028-09-21 Pediatric extension N212480-001 9085573*PED 2028-09-21 Pediatric extension N212480-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 8889159 2029-03-26 U-1470 Drug product 2019-09-23 N212480-001 7964580*PED 2029-09-26 Pediatric extension N212480-001 8633309*PED 2029-09-26 Pediatric extension N212480-001 8889159*PED 2029-09-26 Pediatric extension N212480-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 N212480-001 9284342*PED 2031-03-13 Pediatric extension N212480-001 8618076*PED 2031-06-11 Pediatric extension N212480-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 8334270*PED 2028-09-21 Pediatric extension N212480-002 8580765*PED 2028-09-21 Pediatric extension N212480-002 9085573*PED 2028-09-21 Pediatric extension N212480-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 8889159 2029-03-26 U-1470 Drug product 2019-09-23 N212480-002 7964580*PED 2029-09-26 Pediatric extension N212480-002 8633309*PED 2029-09-26 Pediatric extension N212480-002 8889159*PED 2029-09-26 Pediatric extension N212480-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 N212480-002 9284342*PED 2031-03-13 Pediatric extension N212480-002 8618076*PED 2031-06-11 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 N212480-001 ODE-258 2026-08-28 N212480-002 ODE-258 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 2 · 80 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 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212480-001 SOVALDI 150MG/PACKET PELLETS / ORAL RLD 2019-08-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N212480-002 SOVALDI 200MG/PACKET PELLETS / ORAL RLD, RS 2019-08-28 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 32 · 1,248 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 N212480-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8889159 2029-03-26 U-1470 Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-001 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8334270*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8580765*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 9085573*PED 2028-09-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8889159 2029-03-26 U-1470 Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 7964580*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8633309*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8889159*PED 2029-09-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 9284342 2030-09-13 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8618076 2030-12-11 U-1470 Drug substance, Drug product 2019-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 9284342*PED 2031-03-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212480-002 8618076*PED 2031-06-11 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 8334270 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 8580765 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 9085573 2028-03-21 U-1470 Drug substance, Drug product 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 8334270*PED 2028-09-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 8580765*PED 2028-09-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 9085573*PED 2028-09-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 7964580 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212480-001 8633309 2029-03-26 U-1470 Drug substance, Drug product 2019-09-23 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 182 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sovaldi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOFOSBUVIR 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WJ6CA3ZU8B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1484916 Internal RxNorm lookup 1484922 Internal RxNorm lookup 2203891 Internal RxNorm lookup 2203893 Internal RxNorm lookup 2203993 Internal RxNorm lookup 2203999 Internal RxNorm lookup 2204090 Internal RxNorm lookup 2204092 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 61958-1505-1 Sovaldi 80 in 1 PACKET PELLET 80 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SOFOSBUVIR ACTIVE INGREDIENT WJ6CA3ZU8B SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 SOFOSBUVIR ACTIVE MOIETY WJ6CA3ZU8B SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-1505 SOVALDI (SOFOSBUVIR) TABLET, FILM COATED SOVALDI (SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20250112_80beab2c-396e-4a37-a4dc-40fdb62859cf.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.
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 61958-1505-1 61958150501 80 PELLET in 1 PACKET (61958-1505-1) 80 pellet 2019-08-28 0000-00-00 No No Current