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United States · US · US:63187-910_fdcb382b-4753-45e8-ab3c-28d929c764b7
Tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631879103030 TABLET in 1 BOTTLE, PLASTIC (63187-910-30)
- ndc11631879106060 TABLET in 1 BOTTLE, PLASTIC (63187-910-60)
- ndc11631879109090 TABLET in 1 BOTTLE, PLASTIC (63187-910-90)
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": "63187-910_fdcb382b-4753-45e8-ab3c-28d929c764b7",
"productndc": "63187-910",
"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": "20130401",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
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