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United States · US · US:68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae

Dihydroergotamine Mesylate

Orange BookUNIISPLATC N02CA01

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

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN02CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808346610
    10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
81AXN7R2QT
DIHYDROERGOTAMINE MESYLATE
RxCUI 203176
Orange Book
A215623
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "81AXN7R2QT",
    "rxcui": "203176",
    "inchikey": "ADYPXRFPBQGGAH-UMYZUSPBSA-N",
    "display_name": "DIHYDROERGOTAMINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "b464a64d-b150-4f6b-b3df-e486a41294d7": {
      "match": "brand_token",
      "title": "DIHYDROERGOTAMINE MESYLATE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae",
  "productndc": "68083-466",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215623",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Aug 18, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIHYDROERGOTAMINE MESYLATE",
  "proprietary_name": "Dihydroergotamine Mesylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dihydroergotamine Mesylate",
  "start_marketing_date": "20230818",
  "active_numerator_strength": "1"
}

Related drugs

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