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United States · US · US:66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c

Zavesca

Orange BookUNIIATC A16AX06

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

Identification

ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeA16AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6621520190
    6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)

Annotations

UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
N021348
AB
Raw payload (JSON)
{
  "unii": {
    "unii": "ADN3S497AZ",
    "rxcui": "402316",
    "inchikey": "UQRORFVVSGFNRO-UTINFBMNSA-N",
    "display_name": "MIGLUSTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c",
  "productndc": "66215-201",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021348",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIGLUSTAT",
  "proprietary_name": "Zavesca",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021348",
  "marketing_category": "NDA",
  "nonproprietary_name": "miglustat",
  "start_marketing_date": "20030731",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A16AX06.

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