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United States · US · US:70710-1113_a619e873-810c-450b-bd4e-de0541ed3e63
tizanidine hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11707101113410 BLISTER PACK in 1 CARTON (70710-1113-4) / 10 CAPSULE in 1 BLISTER PACK
- ndc117071011135500 CAPSULE in 1 BOTTLE (70710-1113-5)
- ndc117071011138150 CAPSULE in 1 BOTTLE (70710-1113-8)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A208622
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": "70710-1113_a619e873-810c-450b-bd4e-de0541ed3e63",
"productndc": "70710-1113",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208622",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Mar 3, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Mar 3, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Mar 3, 2017"
}
],
"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": "ANDA208622",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine hydrochloride",
"start_marketing_date": "20170427",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code M03BX02.
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