🇺🇸
United States · US · US:42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb
RYANODEX
Orange BookUNIISPLATC M03CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEagle Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142367540321 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
N205579
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": {
"8f7b3ac0-604d-4c78-b545-5e0f8ea3d698": {
"match": "brand_token",
"title": "RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2024-11-01"
}
},
"productid": "42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb",
"productndc": "42367-540",
"dosage_form": "INJECTION, SUSPENSION",
"orange_book": {
"appl_no": "205579",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Jul 22, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANTROLENE SODIUM",
"proprietary_name": "RYANODEX",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA205579",
"marketing_category": "NDA",
"nonproprietary_name": "dantrolene sodium",
"start_marketing_date": "20140723",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code M03CA01.
Access this data programmatically
Query RYANODEX and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.