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United States · US · US:64980-659_356b3e79-d47b-467a-af62-2adca35f1a2f
tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11649806590330 TABLET in 1 BOTTLE (64980-659-03)
- ndc1164980659101000 TABLET in 1 BOTTLE (64980-659-10)
- ndc116498065915150 TABLET in 1 BOTTLE (64980-659-15)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A218920
ABAB
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": "64980-659_356b3e79-d47b-467a-af62-2adca35f1a2f",
"productndc": "64980-659",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218920",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Aug 7, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Aug 7, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "tizanidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218920",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine",
"start_marketing_date": "20241215",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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