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United States · US · US:42023-124_edb780bb-3d09-4f16-9a76-c263f6de8713
Dantrium
Orange BookUNIISPLATC M03CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeM03CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114202312401100 CAPSULE in 1 BOTTLE (42023-124-01)
Annotations
UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
N017443
ABABAB
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": "ORAL",
"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": "42023-124_edb780bb-3d09-4f16-9a76-c263f6de8713",
"productndc": "42023-124",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "017443",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"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/1",
"application_number": "NDA017443",
"marketing_category": "NDA",
"nonproprietary_name": "dantrolene sodium",
"start_marketing_date": "20080801",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code M03CA01.
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