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United States · US · US:80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4
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 · 3
- ndc11804250448130 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1)
- ndc11804250448260 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2)
- ndc11804250448390 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A210267
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": "80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4",
"productndc": "80425-0448",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210267",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Mar 12, 2019"
}
],
"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": "ANDA210267",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine hydrochloride",
"start_marketing_date": "20241029",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code M03BX02.
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