Back to search
🇺🇸

United States · US · US:80425-0144_43cfb518-01fc-0ea4-e063-6394a90a06d3

Tizanidine HCL

Orange BookUNIISPLATC M03BX02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    8042501441
    30 CAPSULE in 1 BOTTLE (80425-0144-1)
  • ndc11
    8042501442
    60 CAPSULE in 1 BOTTLE (80425-0144-2)
  • ndc11
    8042501443
    90 CAPSULE in 1 BOTTLE (80425-0144-3)
  • ndc11
    8042501444
    120 CAPSULE in 1 BOTTLE (80425-0144-4)

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": {
    "22ea819a-2aaa-44e0-a350-258541b11220": {
      "match": "brand_token",
      "title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "80425-0144_43cfb518-01fc-0ea4-e063-6394a90a06d3",
  "productndc": "80425-0144",
  "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": "Tizanidine HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine HCL",
  "start_marketing_date": "20190329",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code M03BX02.

Access this data programmatically

Query Tizanidine HCL 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.