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United States · US · US:68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac
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
- ndc116878888021100 TABLET in 1 BOTTLE (68788-8802-1)
- ndc11687888802220 TABLET in 1 BOTTLE (68788-8802-2)
- ndc11687888802330 TABLET in 1 BOTTLE (68788-8802-3)
- ndc11687888802660 TABLET in 1 BOTTLE (68788-8802-6)
- ndc116878888028120 TABLET in 1 BOTTLE (68788-8802-8)
- ndc11687888802990 TABLET in 1 BOTTLE (68788-8802-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A091283
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": "68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac",
"productndc": "68788-8802",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091283",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Nov 28, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Nov 28, 2012"
}
],
"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": "ANDA091283",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine",
"start_marketing_date": "20250102",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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