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United States · US · US:0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67f
Dantrolene
Orange BookUNIISPLATC M03CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM03CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439297011 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)
Annotations
UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
A204762
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": {
"c3c45b27-f786-456e-95d6-2e38ef36190a": {
"match": "brand_token",
"title": "DANTROLENE SODIUM CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
"spl_version": "15",
"published_date": "2026-04-30"
}
},
"productid": "0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67f",
"productndc": "0143-9297",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "204762",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/VIAL",
"product_no": "001",
"approval_date": "Jun 19, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANTROLENE SODIUM",
"proprietary_name": "Dantrolene",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204762",
"marketing_category": "ANDA",
"nonproprietary_name": "Dantrolene",
"start_marketing_date": "20170619",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03CA01.
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