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United States · US · US:70515-594_3468e009-cfd1-f217-e063-6294a90a1429
Zanaflex
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117051559415150 TABLET in 1 BOTTLE (70515-594-15)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
N020397
AB
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": "70515-594_3468e009-cfd1-f217-e063-6294a90a1429",
"productndc": "70515-594",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020397",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "Nov 27, 1996"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Feb 4, 2000"
}
],
"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": "NDA020397",
"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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