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United States · US · US:80425-0454_27889dea-01b2-ed7b-e063-6394a90acbc8
tizanidine
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
- ndc11804250454130 TABLET in 1 BOTTLE (80425-0454-1)
- ndc11804250454260 TABLET in 1 BOTTLE (80425-0454-2)
- ndc11804250454390 TABLET in 1 BOTTLE (80425-0454-3)
- ndc118042504544120 TABLET in 1 BOTTLE (80425-0454-4)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A208187
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": "80425-0454_27889dea-01b2-ed7b-e063-6394a90acbc8",
"productndc": "80425-0454",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208187",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Mar 9, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Mar 9, 2018"
}
],
"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": "ANDA208187",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine",
"start_marketing_date": "20241122",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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