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United States · US · US:63629-1673_b87823c8-5dc9-4558-b145-b4b4ff8a7d25
Tizanidine
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc116362916730112 TABLET in 1 BOTTLE (63629-1673-0)
- ndc11636291673130 TABLET in 1 BOTTLE (63629-1673-1)
- ndc11636291673260 TABLET in 1 BOTTLE (63629-1673-2)
- ndc11636291673390 TABLET in 1 BOTTLE (63629-1673-3)
- ndc116362916734120 TABLET in 1 BOTTLE (63629-1673-4)
- ndc11636291673520 TABLET in 1 BOTTLE (63629-1673-5)
- ndc11636291673645 TABLET in 1 BOTTLE (63629-1673-6)
- ndc116362916737140 TABLET in 1 BOTTLE (63629-1673-7)
- ndc11636291673884 TABLET in 1 BOTTLE (63629-1673-8)
- ndc11636291673928 TABLET in 1 BOTTLE (63629-1673-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A076286
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": "63629-1673_b87823c8-5dc9-4558-b145-b4b4ff8a7d25",
"productndc": "63629-1673",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076286",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Jul 3, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Jul 3, 2002"
}
],
"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": "ANDA076286",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidine",
"start_marketing_date": "20020703",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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