NDC 61958-1803

Harvoni

Ledipasvir And Sofosbuvir

Harvoni is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc. The primary component is Ledipasvir; Sofosbuvir.

• Product ID: 61958-1803_6122d2f4-19e4-4aae-89ce-bef7bfc5cb3e
• NDC: 61958-1803
• Product Type: Human Prescription Drug
• Proprietary Name: Harvoni
• Generic Name: Ledipasvir And Sofosbuvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-28
• Marketing Category: NDA / NDA
• Application Number: NDA205834
• Labeler Name: Gilead Sciences, Inc
• Substance Name: LEDIPASVIR; SOFOSBUVIR
• Active Ingredient Strength: 45 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: 2022-12-31

Packaging

NDC 61958-1803-1

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

• Marketing Start Date: 2019-08-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-1803-1 [61958180301]

Harvoni TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205834
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-28

Drug Details

Active Ingredients

Ingredient	Strength
LEDIPASVIR	45 mg/1

OpenFDA Data

• SPL SET ID: f4ec77e4-bae8-4db0-b3d5-bde09c5fa075
• Manufacturer:
  • Gilead Sciences, Inc
• UNII:
  • WJ6CA3ZU8B
  • 013TE6E4WV
• RxNorm Concept Unique ID - RxCUI:
  • 2203895
  • 2203897
  • 1591949
  • 1591943
  • 2204104
  • 2204102
  • 2204103
  • 2204100
• UPC Code:
  • 0361958180313
  • 0361958180115

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 "Harvoni" or generic name "Ledipasvir And Sofosbuvir"

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