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United States · US · US:69528-310_4b1edc20-775b-bb26-e063-6394a90acd08
Ontralfy
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRosemont Pharmaceuticals, LLC
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116952831016473 mL in 1 BOTTLE, PLASTIC (69528-310-16)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
N216190
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B53E3NMY5C",
"rxcui": "236460",
"inchikey": "ZWUKMNZJRDGCTQ-UHFFFAOYSA-N",
"display_name": "TIZANIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7b88c338-c0b7-4c08-bef6-a4ffc2f25df7": {
"match": "brand_token",
"title": "ONTRALFY (TIZANIDINE HYDROCHLORIDE) SOLUTION [ROSEMONT PHARMACEUTICALS, LLC]",
"spl_version": "2",
"published_date": "2026-02-19"
}
},
"productid": "69528-310_4b1edc20-775b-bb26-e063-6394a90acd08",
"productndc": "69528-310",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216190",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 12, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "Ontralfy",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA216190",
"marketing_category": "NDA",
"nonproprietary_name": "Tizanidine Hydrochloride",
"start_marketing_date": "20250331",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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