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United States · US · US:62332-491_451990b5-d759-4025-9373-59f12ab8c267
Tizanidine Hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11623324910880 BLISTER PACK in 1 CARTON (62332-491-08) / 8 CAPSULE in 1 BLISTER PACK
- ndc11623324913030 CAPSULE in 1 BOTTLE (62332-491-30)
- ndc116233249141150 CAPSULE in 1 BOTTLE (62332-491-41)
- ndc1162332491911000 CAPSULE in 1 BOTTLE (62332-491-91)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A213223
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": "62332-491_451990b5-d759-4025-9373-59f12ab8c267",
"productndc": "62332-491",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213223",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Jan 13, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Jan 13, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Jan 13, 2020"
}
],
"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": "ANDA213223",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine Hydrochloride",
"start_marketing_date": "20200115",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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