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United States · US · US:42023-123_dd4a56ce-80e3-4794-94a8-cb2b14695b89

Dantrium

Orange BookUNIISPLATC M03CA01

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

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeM03CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4202312306
    6 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
N018264
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "287M0347EV",
    "rxcui": "3106",
    "inchikey": "LTWQNYPDAUSXBC-CDJGKPBYSA-L",
    "display_name": "DANTROLENE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4df35098-8702-46be-ac67-30cfdf1aa570": {
      "match": "brand_token",
      "title": "DANTRIUM (DANTROLENE SODIUM) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "15",
      "published_date": "2026-04-28"
    }
  },
  "productid": "42023-123_dd4a56ce-80e3-4794-94a8-cb2b14695b89",
  "productndc": "42023-123",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018264",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/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": "DANTROLENE SODIUM",
  "proprietary_name": "Dantrium",
  "active_ingred_unit": "mg/60mL",
  "application_number": "NDA018264",
  "marketing_category": "NDA",
  "nonproprietary_name": "dantrolene sodium",
  "start_marketing_date": "20090420",
  "active_numerator_strength": "20"
}

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