harvoni

Generic: ledipasvir and sofosbuvir

Labeler: gilead sciences, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name harvoni
Generic Name ledipasvir and sofosbuvir
Labeler gilead sciences, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ledipasvir 45 mg/1, sofosbuvir 200 mg/1

Manufacturer
Gilead Sciences, Inc

Identifiers & Regulatory

Product NDC 61958-1803
Product ID 61958-1803_6fc15183-879a-4402-af66-edf57754e31f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205834
Listing Expiration 2026-12-31
Marketing Start 2019-08-28

Pharmacologic Class

Established (EPC)
hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc] hepatitis c virus ns5a inhibitor [epc]
Mechanism of Action
rna replicase inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619581803
Hyphenated Format 61958-1803

Supplemental Identifiers

RxCUI
1591943 1591949 2203895 2203897 2204100 2204102 2204103 2204104
UNII
WJ6CA3ZU8B 013TE6E4WV
NUI
N0000191493 N0000191258 N0000191256 N0000185503 N0000190113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name harvoni (source: ndc)
Generic Name ledipasvir and sofosbuvir (source: ndc)
Application Number NDA205834 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)
source: ndc

Packages (1)

61958-1803-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)

Ingredients (2)

ledipasvir (45 mg/1) sofosbuvir (200 mg/1)

Linked Drug Pages (1)

Harvoni ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6fc15183-879a-4402-af66-edf57754e31f", "openfda": {"nui": ["N0000191493", "N0000191258", "N0000191256", "N0000185503", "N0000190113"], "unii": ["WJ6CA3ZU8B", "013TE6E4WV"], "rxcui": ["1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104"], "spl_set_id": ["f4ec77e4-bae8-4db0-b3d5-bde09c5fa075"], "pharm_class_epc": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "Hepatitis C Virus NS5A Inhibitor [EPC]"], "pharm_class_moa": ["RNA Replicase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)", "package_ndc": "61958-1803-1", "marketing_start_date": "20190828"}], "brand_name": "Harvoni", "product_id": "61958-1803_6fc15183-879a-4402-af66-edf57754e31f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "61958-1803", "generic_name": "ledipasvir and sofosbuvir", "labeler_name": "Gilead Sciences, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Harvoni", "active_ingredients": [{"name": "LEDIPASVIR", "strength": "45 mg/1"}, {"name": "SOFOSBUVIR", "strength": "200 mg/1"}], "application_number": "NDA205834", "marketing_category": "NDA", "marketing_start_date": "20190828", "listing_expiration_date": "20261231"}