Veklury

Orange BookUNIISPLATC J05AB16

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGilead Sciences, Inc.

CountryUS (United States)

ATC codeJ05AB16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6195829012
1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

3QKI37EEHE

REMDESIVIR

RxCUI 2284718

Orange Book

N214787

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3QKI37EEHE",
    "rxcui": "2284718",
    "inchikey": "RWWYLEGWBNMMLJ-YSOARWBDSA-N",
    "display_name": "REMDESIVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c0978fa8-53ff-4ca2-82a7-567fd3e958ca": {
      "match": "brand_token",
      "title": "VEKLURY (REMDESIVIR) INJECTION VEKLURY (REMDESIVIR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GILEAD SCIENCES, INC.]",
      "spl_version": "23",
      "published_date": "2026-02-17"
    }
  },
  "productid": "61958-2901_2399f66f-aacb-4743-8117-b722c91b4bac",
  "productndc": "61958-2901",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214787",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 22, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 22, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REMDESIVIR",
  "proprietary_name": "Veklury",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214787",
  "marketing_category": "NDA",
  "nonproprietary_name": "remdesivir",
  "start_marketing_date": "20201101",
  "active_numerator_strength": "100"
}

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