FDA.reportPublic FDA data

Harvoni

Product NDC
61958-1805
11-digit product format
619581805
Labeler code
61958
Product ID
61958-1805_6fc15183-879a-4402-af66-edf57754e31f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ledipasvir and sofosbuvir
Dosage form
PELLET
Route
ORAL
Labeler
Gilead Sciences, Inc
Application
NDA212477
Marketing category
NDA
Marketing start
2019-08-28
Substance
LEDIPASVIR; SOFOSBUVIR
Active strength
33.75; 150 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

Additional Listing Data#

Finished product
Yes
Brand name base
Harvoni
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEDIPASVIR33.75 mg/1
SOFOSBUVIR150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWJ6CA3ZU8B, 013TE6E4WV
Rxcui1591943, 1591949, 2203895, 2203897, 2204100, 2204102, 2204103, 2204104

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
92f2ba3e-4d65-41e6-a610-6d4b30045f53Product name320220118
4b0175e6-7a5b-49b7-bb68-cb6baadf8704Product name220200213
67bfd237-f3a6-4139-9e2c-fe97fb0f8bc0Product name220200213
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a9351c76-435b-43d8-966c-be983b09b034Product name120170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1805-1Harvoni90 in 1 PACKETPELLET9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-1805-1EA - Each61958-18054f6681e0-f3a1-4afd-9727-e83a825837c512020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEDIPASVIRACTIVE INGREDIENT013TE6E4WVHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SOFOSBUVIRACTIVE INGREDIENTWJ6CA3ZU8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
LEDIPASVIRACTIVE MOIETY013TE6E4WVHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SOFOSBUVIRACTIVE MOIETYWJ6CA3ZU8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1805HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC]17Current NDC, Legacy NDC, 1 package rows20250112_f4ec77e4-bae8-4db0-b3d5-bde09c5fa075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2204102Harvoni 33.75 MG / 150 MG per packet Oral PelletsPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2203897Harvoni 45 MG / 200 MG Oral TabletPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204104Harvoni 45 MG / 200 MG per packet Oral PelletsPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
1591949Harvoni 90 MG / 400 MG Oral TabletPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204100ledipasvir 33.75 MG / sofosbuvir 150 MG per packet Oral PelletsPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2203895ledipasvir 45 MG / sofosbuvir 200 MG Oral TabletPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204103ledipasvir 45 MG / sofosbuvir 200 MG per packet Oral PelletsPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
1591943ledipasvir 90 MG / sofosbuvir 400 MG Oral TabletPSNf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204102ledipasvir 33.75 MG / sofosbuvir 150 MG Oral Pellet [Harvoni]SBDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204104ledipasvir 45 MG / sofosbuvir 200 MG Oral Pellet [Harvoni]SBDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2203897ledipasvir 45 MG / sofosbuvir 200 MG Oral Tablet [Harvoni]SBDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
1591949ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet [Harvoni]SBDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204100ledipasvir 33.75 MG / sofosbuvir 150 MG Oral PelletSCDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204103ledipasvir 45 MG / sofosbuvir 200 MG Oral PelletSCDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2203895ledipasvir 45 MG / sofosbuvir 200 MG Oral TabletSCDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
1591943ledipasvir 90 MG / sofosbuvir 400 MG Oral TabletSCDf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204102Harvoni (ledipasvir 33.75 MG / sofosbuvir 150 MG) per packet Oral PelletsSYf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2203897Harvoni (ledipasvir 45 MG / sofosbuvir 200 MG) Oral TabletSYf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
2204104Harvoni (ledipasvir 45 MG / sofosbuvir 200 MG) per packet Oral PelletsSYf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517
1591949Harvoni (ledipasvir 90 MG / sofosbuvir 400 MG) Oral TabletSYf4ec77e4-bae8-4db0-b3d5-bde09c5fa07517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-1805-16195818050190 PELLET in 1 PACKET (61958-1805-1) 90 pellet2019-08-280000-00-00NoNoCurrent