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United States · US · US:60505-0251_95820c11-e6e2-4f26-6af9-2cc60ef94c41
tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116050502511100 TABLET in 1 BOTTLE (60505-0251-1)
- ndc1160505025121000 TABLET in 1 BOTTLE (60505-0251-2)
- ndc116050502513150 TABLET in 1 BOTTLE (60505-0251-3)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A076533
ABAB
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": {
"22ea819a-2aaa-44e0-a350-258541b11220": {
"match": "brand_token",
"title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "60505-0251_95820c11-e6e2-4f26-6af9-2cc60ef94c41",
"productndc": "60505-0251",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076533",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Jan 16, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Jan 16, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "tizanidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076533",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine",
"start_marketing_date": "20040116",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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