Tizanidine

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642086600
1000 TABLET in 1 BOTTLE (76420-866-00)
ndc11
7642086612
120 TABLET in 1 BOTTLE (76420-866-12)
ndc11
7642086615
150 TABLET in 1 BOTTLE (76420-866-15)
ndc11
7642086630
30 TABLET in 1 BOTTLE (76420-866-30)
ndc11
7642086660
60 TABLET in 1 BOTTLE (76420-866-60)
ndc11
7642086690
90 TABLET in 1 BOTTLE (76420-866-90)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

A076286

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": "76420-866_259ac6fd-2a83-04c0-e063-6394a90af566",
  "productndc": "76420-866",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076286",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jul 3, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jul 3, 2002"
      }
    ],
    "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": "ANDA076286",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine",
  "start_marketing_date": "20210615",
  "active_numerator_strength": "4"
}

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