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United States · US · US:80425-0187_21edbe60-524e-b675-e063-6294a90ad2d6
Tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250187130 TABLET in 1 BOTTLE (80425-0187-1)
- ndc11804250187260 TABLET in 1 BOTTLE (80425-0187-2)
- ndc11804250187390 TABLET in 1 BOTTLE (80425-0187-3)
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": "80425-0187_21edbe60-524e-b675-e063-6294a90ad2d6",
"productndc": "80425-0187",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091283",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine",
"start_marketing_date": "20130401",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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