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United States · US · US:0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575

Cortrosyn

Orange BookUNIISPLATC H01AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmphastar Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeH01AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0548590000
    10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
72YY86EA29
COSYNTROPIN
RxCUI 2890
Orange Book
N016750
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "72YY86EA29",
    "rxcui": "2890",
    "inchikey": null,
    "display_name": "COSYNTROPIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "0c424fac-b114-41f6-aba8-cf710a34c26c": {
      "match": "brand_token",
      "title": "CORTROSYN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HENRY SCHEIN, INC.]",
      "spl_version": "6",
      "published_date": "2025-06-19"
    }
  },
  "productid": "0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575",
  "productndc": "0548-5900",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "016750",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25MG/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COSYNTROPIN",
  "proprietary_name": "Cortrosyn",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA016750",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cosyntropin",
  "start_marketing_date": "20030801",
  "active_numerator_strength": ".25"
}

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