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United States · US · US:84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6
Revonto
Orange BookUNIISPLATC M03CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProPharma Distribution
CountryUS (United States)
ATC codeM03CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11845490036760 mL in 1 VIAL, GLASS (84549-003-67)
Annotations
UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
A078378
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": {
"3edcfad5-00ad-7587-e063-6394a90addf3": {
"match": "brand_token",
"title": "REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROPHARMA DISTRIBUTION]",
"spl_version": "2",
"published_date": "2025-12-19"
}
},
"productid": "84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6",
"productndc": "84549-003",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "078378",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/VIAL",
"product_no": "001",
"approval_date": "Jul 24, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANTROLENE SODIUM",
"proprietary_name": "Revonto",
"active_ingred_unit": "mg/60mL",
"application_number": "ANDA078378",
"marketing_category": "ANDA",
"nonproprietary_name": "dantrolene sodium",
"start_marketing_date": "20210409",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03CA01.
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