Glucagon

Orange BookSPL

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378806790
1 KIT in 1 KIT (0378-8067-90) * 1 mL in 1 VIAL (0378-8065-32) * 1 mL in 1 SYRINGE (0378-8066-32)

Annotations

Orange Book

A204468

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "9d0fbe4e-6120-4f69-b06d-c939eaeb7708": {
      "match": "brand_token",
      "title": "GLUCAGON KIT [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "0378-8067_e1d65360-2785-4308-8a64-5c2c9e812868",
  "productndc": "0378-8067",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204468",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Glucagon",
  "active_ingred_unit": null,
  "application_number": "ANDA204468",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glucagon",
  "start_marketing_date": "20250226",
  "active_numerator_strength": null
}

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