TIZANIDINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerTIZANIDINE HYDROCHLORIDE

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6191919620
20 TABLET in 1 BOTTLE (61919-196-20)
ndc11
6191919630
30 TABLET in 1 BOTTLE (61919-196-30)
ndc11
6191919640
40 TABLET in 1 BOTTLE (61919-196-40)
ndc11
6191919660
60 TABLET in 1 BOTTLE (61919-196-60)
ndc11
6191919672
72 TABLET in 1 BOTTLE (61919-196-72)
ndc11
6191919690
90 TABLET in 1 BOTTLE (61919-196-90)

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": {
    "22ea819a-2aaa-44e0-a350-258541b11220": {
      "match": "brand_token",
      "title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "61919-196_4c484458-33e2-e0cc-e063-6294a90a9e28",
  "productndc": "61919-196",
  "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": "TIZANIDINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091283",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TIZANIDINE HYDROCHLORIDE",
  "start_marketing_date": "20140101",
  "active_numerator_strength": "4"
}

Related drugs

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