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United States · US · US:80425-0024_2a984dd9-7291-77f0-e063-6294a90a8f1e
Tizanidine HCL
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11804250024160 TABLET in 1 BOTTLE (80425-0024-1)
- ndc11804250024290 TABLET in 1 BOTTLE (80425-0024-2)
- ndc11804250024330 TABLET in 1 BOTTLE (80425-0024-3)
- ndc118042500244120 TABLET in 1 BOTTLE (80425-0024-4)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A091283
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": "80425-0024_2a984dd9-7291-77f0-e063-6294a90a8f1e",
"productndc": "80425-0024",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091283",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Nov 28, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Nov 28, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "Tizanidine HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091283",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine HCL",
"start_marketing_date": "20130401",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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