tizanidine

Orange BookUNIISPLATC M03BX02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerViona Pharmaceuticals Inc

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7257809706
30 TABLET in 1 BOTTLE (72578-097-06)
ndc11
7257809710
1000 TABLET in 1 BOTTLE (72578-097-10)
ndc11
7257809721
150 TABLET in 1 BOTTLE (72578-097-21)
ndc11
7257809776
300 TABLET in 1 BOTTLE (72578-097-76)
ndc11
7257809777
10 BLISTER PACK in 1 CARTON (72578-097-77) / 10 TABLET in 1 BLISTER PACK (72578-097-30)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

A208187

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": {
    "22ea819a-2aaa-44e0-a350-258541b11220": {
      "match": "brand_token",
      "title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "72578-097_8fd84300-3ed6-42ff-b20c-608ea5dc96eb",
  "productndc": "72578-097",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208187",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Mar 9, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Mar 9, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIZANIDINE HYDROCHLORIDE",
  "proprietary_name": "tizanidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208187",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tizanidine",
  "start_marketing_date": "20210304",
  "active_numerator_strength": "4"
}

Related drugs

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