NDC 72626-2601

Ledipasvir and Sofosbuvir

Ledipasvir And Sofosbuvir

Ledipasvir and Sofosbuvir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Asegua Therapeutics Llc. The primary component is Ledipasvir; Sofosbuvir.

• Product ID: 72626-2601_0b79cdc4-32f3-4ec4-bad6-768a3a9378cd
• NDC: 72626-2601
• Product Type: Human Prescription Drug
• Proprietary Name: Ledipasvir and Sofosbuvir
• Generic Name: Ledipasvir And Sofosbuvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-14
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA205834
• Labeler Name: Asegua Therapeutics LLC
• Substance Name: LEDIPASVIR; SOFOSBUVIR
• Active Ingredient Strength: 90 mg/1; mg/1
• Pharm Classes: Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 72626-2601-1

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

• Marketing Start Date: 2019-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72626-2601-1 [72626260101]

Ledipasvir and Sofosbuvir TABLET, FILM COATED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA205834
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-01

Drug Details

Active Ingredients

Ingredient	Strength
LEDIPASVIR	90 mg/1

OpenFDA Data

• SPL SET ID: 46f4a73b-0cd6-4902-9092-3ac79e882c1a
• Manufacturer:
  • Asegua Therapeutics LLC
• UNII:
  • WJ6CA3ZU8B
  • 013TE6E4WV
• RxNorm Concept Unique ID - RxCUI:
  • 1591943

Pharmacological Class

• Hepatitis C Virus NS5A Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
• RNA Replicase Inhibitors [MoA]
• Nucleoside Analog [EXT]

NDC Crossover Matching brand name "Ledipasvir and Sofosbuvir" or generic name "Ledipasvir And Sofosbuvir"

NDC	Brand Name	Generic Name
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR
61958-1803	Harvoni	ledipasvir and sofosbuvir
61958-1804	Harvoni	ledipasvir and sofosbuvir
61958-1805	Harvoni	ledipasvir and sofosbuvir