sovaldi

Generic: sofosbuvir

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

Drug Facts

Product Profile

Brand Name sovaldi
Generic Name sofosbuvir
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sofosbuvir 200 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1503
Product ID 61958-1503_74c52ec6-8358-4e63-b299-64ec1ff7f434
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204671
Listing Expiration 2026-12-31
Marketing Start 2019-08-28

Pharmacologic Class

Established (EPC)
hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc]
Mechanism of Action
rna replicase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619581503
Hyphenated Format 61958-1503

Supplemental Identifiers

RxCUI
1484916 1484922 2203891 2203893 2203993 2203999 2204090 2204092
UNII
WJ6CA3ZU8B
NUI
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 sovaldi (source: ndc)
Generic Name sofosbuvir (source: ndc)
Application Number NDA204671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1)
source: ndc

Packages (1)

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

Ingredients (1)

sofosbuvir (200 mg/1)

Linked Drug Pages (1)

Sovaldi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "74c52ec6-8358-4e63-b299-64ec1ff7f434", "openfda": {"nui": ["N0000191493", "N0000191258"], "unii": ["WJ6CA3ZU8B"], "rxcui": ["1484916", "1484922", "2203891", "2203893", "2203993", "2203999", "2204090", "2204092"], "spl_set_id": ["80beab2c-396e-4a37-a4dc-40fdb62859cf"], "pharm_class_epc": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["RNA Replicase Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1)", "package_ndc": "61958-1503-1", "marketing_start_date": "20190828"}], "brand_name": "Sovaldi", "product_id": "61958-1503_74c52ec6-8358-4e63-b299-64ec1ff7f434", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]", "RNA Replicase Inhibitors [MoA]"], "product_ndc": "61958-1503", "generic_name": "SOFOSBUVIR", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sovaldi", "active_ingredients": [{"name": "SOFOSBUVIR", "strength": "200 mg/1"}], "application_number": "NDA204671", "marketing_category": "NDA", "marketing_start_date": "20190828", "listing_expiration_date": "20261231"}