veklury

Generic: remdesivir

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

Drug Facts

Product Profile

Brand Name veklury
Generic Name remdesivir
Labeler gilead sciences, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

remdesivir 100 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-2901
Product ID 61958-2901_2399f66f-aacb-4743-8117-b722c91b4bac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214787
Listing Expiration 2027-12-31
Marketing Start 2020-11-01

Pharmacologic Class

Established (EPC)
sars-cov-2 nucleotide analog rna polymerase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619582901
Hyphenated Format 61958-2901

Supplemental Identifiers

RxCUI
2284960 2367758 2395502 2395504
UNII
3QKI37EEHE
NUI
N0000193948

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 veklury (source: ndc)
Generic Name remdesivir (source: ndc)
Application Number NDA214787 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

61958-2901-2 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

remdesivir (100 mg/1)

Linked Drug Pages (1)

Veklury ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2399f66f-aacb-4743-8117-b722c91b4bac", "openfda": {"nui": ["N0000193948"], "unii": ["3QKI37EEHE"], "rxcui": ["2284960", "2367758", "2395502", "2395504"], "spl_set_id": ["c0978fa8-53ff-4ca2-82a7-567fd3e958ca"], "pharm_class_epc": ["SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor [EPC]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "61958-2901-2", "marketing_start_date": "20201101"}], "brand_name": "Veklury", "product_id": "61958-2901_2399f66f-aacb-4743-8117-b722c91b4bac", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor [EPC]"], "product_ndc": "61958-2901", "generic_name": "remdesivir", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Veklury", "active_ingredients": [{"name": "REMDESIVIR", "strength": "100 mg/1"}], "application_number": "NDA214787", "marketing_category": "NDA", "marketing_start_date": "20201101", "listing_expiration_date": "20271231"}