TIZANIDINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerNivagen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7583420815
150 CAPSULE in 1 BOTTLE (75834-208-15)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

A210021

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": "75834-208_359eaf8b-a8f7-4493-ba61-98e106bcc3d5",
  "productndc": "75834-208",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210021",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Mar 26, 2019"
      }
    ],
    "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": "ANDA210021",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TIZANIDINE HYDROCHLORIDE",
  "start_marketing_date": "20190926",
  "active_numerator_strength": "4"
}

Related drugs

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