ledipasvir and sofosbuvir (72626-2601)

Drug Facts

Product Profile

Brand Name ledipasvir and sofosbuvir

Generic Name ledipasvir and sofosbuvir

Labeler asegua therapeutics llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

ledipasvir 90 mg/1, sofosbuvir 400 mg/1

Manufacturer

Asegua Therapeutics LLC

Identifiers & Regulatory

Product NDC 72626-2601

Product ID 72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA AUTHORIZED GENERIC

Application Number NDA205834

Listing Expiration 2026-12-31

Marketing Start 2019-01-01

Pharmacologic Class

Established (EPC)

hepatitis c virus ns5a inhibitor [epc] hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc]

Mechanism of Action

p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] rna replicase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 726262601

Hyphenated Format 72626-2601

Supplemental Identifiers

RxCUI

1591943

UNII

013TE6E4WV WJ6CA3ZU8B

NUI

N0000191256 N0000185503 N0000190113 N0000191493 N0000191258

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 ledipasvir and sofosbuvir (source: ndc)

Generic Name ledipasvir and sofosbuvir (source: ndc)

Application Number NDA205834 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

90 mg/1
400 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (1)

72626-2601-1 2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

ledipasvir (90 mg/1) sofosbuvir (400 mg/1)

Linked Drug Pages (1)

Ledipasvir and Sofosbuvir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "bd8387fe-8338-4241-b084-aec76726f8a9", "openfda": {"nui": ["N0000191256", "N0000185503", "N0000190113", "N0000191493", "N0000191258"], "unii": ["013TE6E4WV", "WJ6CA3ZU8B"], "rxcui": ["1591943"], "spl_set_id": ["46f4a73b-0cd6-4902-9092-3ac79e882c1a"], "pharm_class_epc": ["Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]"], "manufacturer_name": ["Asegua Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (72626-2601-1)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "72626-2601-1", "marketing_start_date": "20190101"}], "brand_name": "Ledipasvir and Sofosbuvir", "product_id": "72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9", "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": "72626-2601", "generic_name": "Ledipasvir and Sofosbuvir", "labeler_name": "Asegua Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ledipasvir and Sofosbuvir", "active_ingredients": [{"name": "LEDIPASVIR", "strength": "90 mg/1"}, {"name": "SOFOSBUVIR", "strength": "400 mg/1"}], "application_number": "NDA205834", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190101", "listing_expiration_date": "20261231"}