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United States · US · US:76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad

ATZUMI

Orange BookUNIISPLATC N02CA01

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

Identification

ManufacturerSatsuma Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN02CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7697810108
    8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE
  • ndc11
    7697810111
    1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE

Annotations

UNII (FDA Substance ID)
81AXN7R2QT
DIHYDROERGOTAMINE MESYLATE
RxCUI 203176
Orange Book
N217901
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": "NASAL",
  "spl_meta": {
    "0982a44a-dc0c-75c0-e063-6394a90a6d6c": {
      "match": "brand_token",
      "title": "ATZUMI (DIHYDROERGOTAMINE MESYLATE) POWDER [SATSUMA PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-05-15"
    }
  },
  "productid": "76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad",
  "productndc": "76978-101",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "217901",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5.2MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIHYDROERGOTAMINE MESYLATE",
  "proprietary_name": "ATZUMI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217901",
  "marketing_category": "NDA",
  "nonproprietary_name": "DIHYDROERGOTAMINE MESYLATE",
  "start_marketing_date": "20250430",
  "active_numerator_strength": "5.2"
}

Related drugs

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