Glucagon

Orange BookSPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332359303
1 KIT in 1 CARTON (63323-593-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-03) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-185-03)

Annotations

Orange Book

N201849

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": "63323-593_eb37fc8a-a264-4ce9-a130-466e9b5f3a38",
  "productndc": "63323-593",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201849",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Sep 19, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Glucagon",
  "active_ingred_unit": null,
  "application_number": "NDA201849",
  "marketing_category": "NDA",
  "nonproprietary_name": "Glucagon",
  "start_marketing_date": "20150508",
  "active_numerator_strength": null
}

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