🇺🇸
United States · US · US:68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae
Tizanidne hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878887981100 CAPSULE in 1 BOTTLE (68788-8798-1)
- ndc11687888798220 CAPSULE in 1 BOTTLE (68788-8798-2)
- ndc11687888798330 CAPSULE in 1 BOTTLE (68788-8798-3)
- ndc11687888798660 CAPSULE in 1 BOTTLE (68788-8798-6)
- ndc116878887988120 CAPSULE in 1 BOTTLE (68788-8798-8)
- ndc11687888798990 CAPSULE in 1 BOTTLE (68788-8798-9)
Annotations
UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A212196
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": {
"226b506f-6f85-48e8-b8e5-86442d74d951": {
"match": "brand_token",
"title": "TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-05-25"
}
},
"productid": "68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae",
"productndc": "68788-8798",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212196",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "Mar 27, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "Mar 27, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "Mar 27, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIZANIDINE HYDROCHLORIDE",
"proprietary_name": "Tizanidne hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212196",
"marketing_category": "ANDA",
"nonproprietary_name": "Tizanidne Hydrochloride",
"start_marketing_date": "20250101",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
Access this data programmatically
Query Tizanidne hydrochloride 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.