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United States · US · US:68788-8741_3c847e6e-2f52-43c6-9ba6-83729cb4662f
tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878887411100 TABLET in 1 BOTTLE (68788-8741-1)
- ndc11687888741220 TABLET in 1 BOTTLE (68788-8741-2)
- ndc11687888741330 TABLET in 1 BOTTLE (68788-8741-3)
- ndc11687888741660 TABLET in 1 BOTTLE (68788-8741-6)
- ndc116878887418120 TABLET in 1 BOTTLE (68788-8741-8)
- ndc11687888741990 TABLET in 1 BOTTLE (68788-8741-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A076533
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": "68788-8741_3c847e6e-2f52-43c6-9ba6-83729cb4662f",
"productndc": "68788-8741",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076533",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Jan 16, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Jan 16, 2004"
}
],
"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": "ANDA076533",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine",
"start_marketing_date": "20240920",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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