Glucagon

Orange BookSPL

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

Identification

ManufacturerAmphastar Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0548585000
1 KIT in 1 KIT (0548-5850-00) * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00)

Annotations

Orange Book

A208086

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": "0548-5850_7b1b15a9-4632-4749-b4ad-95dd0c5d3966",
  "productndc": "0548-5850",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208086",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Glucagon",
  "active_ingred_unit": null,
  "application_number": "ANDA208086",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glucagon",
  "start_marketing_date": "20210210",
  "active_numerator_strength": null
}

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