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United States · US · US:72162-2045_57a49e45-2998-4eda-9eac-fe843ceeb892
Dantrolene Sodium
Orange BookUNIISPLATC M03CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117216220451100 CAPSULE in 1 BOTTLE (72162-2045-1)
Annotations
UNII (FDA Substance ID)
287M0347EV
DANTROLENE SODIUM
RxCUI 3106
Orange Book
A076686
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": {
"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": "72162-2045_57a49e45-2998-4eda-9eac-fe843ceeb892",
"productndc": "72162-2045",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "076686",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Oct 24, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Oct 24, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Oct 24, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANTROLENE SODIUM",
"proprietary_name": "Dantrolene Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076686",
"marketing_category": "ANDA",
"nonproprietary_name": "dantrolene sodium",
"start_marketing_date": "20051026",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code M03CA01.
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