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United States · US · US:80425-0474_43cfd33c-ce85-2381-e063-6394a90a4f1a
tizanidine hydrochloride
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
- ndc11804250474130 CAPSULE in 1 BOTTLE (80425-0474-1)
- ndc11804250474260 CAPSULE in 1 BOTTLE (80425-0474-2)
- ndc11804250474390 CAPSULE in 1 BOTTLE (80425-0474-3)
- ndc118042504744120 CAPSULE in 1 BOTTLE (80425-0474-4)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A213798
ABABAB
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": "80425-0474_43cfd33c-ce85-2381-e063-6394a90a4f1a",
"productndc": "80425-0474",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213798",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "May 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "May 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "May 27, 2020"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 8MG BASE",
"product_no": "004",
"approval_date": "Aug 28, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "tizanidine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213798",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine hydrochloride",
"start_marketing_date": "20250120",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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