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United States · US · US:68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b
TIZANIDINE HYDROCHLORIDE
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 · 4
- ndc116878884781100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1)
- ndc11687888478330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3)
- ndc11687888478660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6)
- ndc11687888478990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A210267
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": "68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b",
"productndc": "68788-8478",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210267",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Mar 12, 2019"
}
],
"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": "ANDA210267",
"marketing_category": "ANDA",
"nonproprietary_name": "tizanidine hydrochloride",
"start_marketing_date": "20230706",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code M03BX02.
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