Gvoke VialDx

Orange BookUNIISPLATC H04AA01

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC codeH04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0517290101
1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL
ndc11
0517290110
10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

76LA80IG2G

GLUCAGON

RxCUI 4832

Orange Book

N212097

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "76LA80IG2G",
    "rxcui": "4832",
    "inchikey": null,
    "display_name": "GLUCAGON",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "92385737-dbad-98c5-e053-2995a90a2805": {
      "match": "brand_token",
      "title": "GVOKE HYPOPEN 1 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 1 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 0.5 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE KIT (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION [XERIS PHARMACEUTICALS, INC.]",
      "spl_version": "20",
      "published_date": "2026-01-23"
    }
  },
  "productid": "0517-2901_394a5780-8ead-4c26-890c-37edfb879599",
  "productndc": "0517-2901",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212097",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/0.1ML (0.5MG/0.1ML)",
        "product_no": "001",
        "approval_date": "Sep 10, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/0.2ML (1MG/0.2ML)",
        "product_no": "002",
        "approval_date": "Sep 10, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/0.1ML (0.5MG/0.1ML)",
        "product_no": "003",
        "approval_date": "Sep 10, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/0.2ML (1MG/0.2ML)",
        "product_no": "004",
        "approval_date": "Sep 10, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/0.2ML (1MG/0.2ML)",
        "product_no": "005",
        "approval_date": "Aug 20, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/0.2ML (1MG/0.2ML)",
        "product_no": "006",
        "approval_date": "Mar 14, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLUCAGON",
  "proprietary_name": "Gvoke VialDx",
  "active_ingred_unit": "mg/.2mL",
  "application_number": "NDA212097",
  "marketing_category": "NDA",
  "nonproprietary_name": "glucagon injection",
  "start_marketing_date": "20250819",
  "active_numerator_strength": "1"
}

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