NDC 61958-1503

Sovaldi

Sofosbuvir

Sovaldi 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 Sofosbuvir.

• Product ID: 61958-1503_10e67d0d-c67d-4971-a948-b733c476e603
• NDC: 61958-1503
• Product Type: Human Prescription Drug
• Proprietary Name: Sovaldi
• Generic Name: Sofosbuvir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-28
• Marketing Category: NDA / NDA
• Application Number: NDA204671
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: SOFOSBUVIR
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 61958-1503-1

28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1)

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

NDC SPL Data Element Entries

NDC 61958-1503-1 [61958150301]

Sovaldi TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204671
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-28

Drug Details

Active Ingredients

Ingredient	Strength
SOFOSBUVIR	200 mg/1

OpenFDA Data

• SPL SET ID: 80beab2c-396e-4a37-a4dc-40fdb62859cf
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • WJ6CA3ZU8B
• RxNorm Concept Unique ID - RxCUI:
  • 1484916
  • 1484922
  • 2203999
  • 2203891
  • 2203893
  • 2203993
  • 2204092
  • 2204090
• UPC Code:
  • 0361958150316

Pharmacological Class

• Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
• RNA Replicase Inhibitors [MoA]
• Nucleoside Analog [EXT]

NDC Crossover Matching brand name "Sovaldi" or generic name "Sofosbuvir"

NDC	Brand Name	Generic Name
61958-1501	Sovaldi	SOFOSBUVIR
61958-1503	Sovaldi	SOFOSBUVIR
61958-1504	Sovaldi	SOFOSBUVIR
61958-1505	Sovaldi	SOFOSBUVIR