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United States · US · US:83107-002_476ae6e6-0732-af36-e063-6394a90a7c02
Zanaflex
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLegacy Pharma USA, Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118310700215150 CAPSULE in 1 BOTTLE (83107-002-15)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
N021447
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": {
"60c27d35-7349-4fc6-86ad-70fffdbe3e08": {
"match": "brand_token",
"title": "ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.]",
"spl_version": "2",
"published_date": "2026-01-05"
}
},
"productid": "83107-002_476ae6e6-0732-af36-e063-6394a90a7c02",
"productndc": "83107-002",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021447",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Aug 29, 2002"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Aug 29, 2002"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Aug 29, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "Zanaflex",
"active_ingred_unit": "mg/1",
"application_number": "NDA021447",
"marketing_category": "NDA",
"nonproprietary_name": "tizanidine hydrochloride",
"start_marketing_date": "20180801",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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