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United States · US · US:60505-2648_f68c762c-26fc-7c61-1a94-6b5110937eea
Tizanidine Hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11605052648330 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-3)
- ndc116050526487150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-7)
- ndc1160505264881000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-8)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A078868
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": "60505-2648_f68c762c-26fc-7c61-1a94-6b5110937eea",
"productndc": "60505-2648",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "078868",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Feb 3, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Feb 3, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Feb 3, 2012"
}
],
"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": "ANDA078868",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine Hydrochloride",
"start_marketing_date": "20120206",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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