Tizanidine Hydrochloride

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerQuality Care Products LLC

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4999934701
120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01)
ndc11
4999934730
30 TABLET in 1 BOTTLE, PLASTIC (49999-347-30)
ndc11
4999934760
60 TABLET in 1 BOTTLE, PLASTIC (49999-347-60)
ndc11
4999934790
90 TABLET in 1 BOTTLE, PLASTIC (49999-347-90)

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": "49999-347_adbf3ce7-64fd-4df3-aa6f-9f4b459b2976",
  "productndc": "49999-347",
  "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076286",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine Hydrochloride",
  "start_marketing_date": "20101123",
  "active_numerator_strength": "4"
}

Related drugs

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