🇺🇸
United States · US · US:61919-811_4c49db13-77a7-a9db-e063-6294a90a3197
TIZANDINE
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116191981182180 TABLET in 1 BOTTLE (61919-811-82)
- ndc11619198119090 TABLET in 1 BOTTLE (61919-811-90)
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": {
"9003cb5d-f9d6-7183-e053-2995a90ad6e8": {
"match": "brand_token",
"title": "TIZANDINE TABLET [DIRECT_RX]",
"spl_version": "3",
"published_date": "2026-03-09"
}
},
"productid": "61919-811_4c49db13-77a7-a9db-e063-6294a90a3197",
"productndc": "61919-811",
"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": "TIZANDINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091283",
"marketing_category": "ANDA",
"nonproprietary_name": "TIZANDINE",
"start_marketing_date": "20190813",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code M03BX02.
Access this data programmatically
Query TIZANDINE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.