Home NDC 61958-1801 Harvoni
Product NDC 61958-1801
11-digit product format 619581801
Labeler code 61958
Product ID 61958-1801_6fc15183-879a-4402-af66-edf57754e31f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEDIPASVIR and SOFOSBUVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc
Application NDA205834
Marketing category NDA
Marketing start 2014-10-10
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 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 Harvoni
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1591943 Internal RxNorm lookup 1591949 Internal RxNorm lookup 2203895 Internal RxNorm lookup 2203897 Internal RxNorm lookup 2204100 Internal RxNorm lookup 2204102 Internal RxNorm lookup 2204103 Internal RxNorm lookup 2204104 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 61958-1801-1 Harvoni 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEDIPASVIR ACTIVE INGREDIENT 013TE6E4WV HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 SOFOSBUVIR ACTIVE INGREDIENT WJ6CA3ZU8B HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 LEDIPASVIR ACTIVE MOIETY 013TE6E4WV HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 SOFOSBUVIR ACTIVE MOIETY WJ6CA3ZU8B HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-1801 HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC] 17 Current NDC, Legacy NDC, 1 package rows 20250112_f4ec77e4-bae8-4db0-b3d5-bde09c5fa075.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 Marketing start Marketing end Sample Exclude flag Status 61958-1801-1 61958180101 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1) 2014-10-10 0000-00-00 No No Current