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United States · US · US:67877-611_628c23e5-c9ed-453b-a83e-1514d6b02912
Tizanidne hydrochloride
Orange BookUNIISPLATC M03BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116787761105500 CAPSULE in 1 BOTTLE (67877-611-05)
- ndc116787761115150 CAPSULE in 1 BOTTLE (67877-611-15)
- ndc1167877611331 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK
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": "67877-611_628c23e5-c9ed-453b-a83e-1514d6b02912",
"productndc": "67877-611",
"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": "20190329",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code M03BX02.
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