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United States · US · US:70771-1069_e5aa06ec-9ceb-4c1c-9334-90bef0d9366f
tizanidine hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11707711069410 BLISTER PACK in 1 CARTON (70771-1069-4) / 10 CAPSULE in 1 BLISTER PACK
- ndc117077110695500 CAPSULE in 1 BOTTLE (70771-1069-5)
- ndc117077110698150 CAPSULE in 1 BOTTLE (70771-1069-8)
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": "70771-1069_e5aa06ec-9ceb-4c1c-9334-90bef0d9366f",
"productndc": "70771-1069",
"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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