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United States · US · US:71335-0424_2ea6e19f-4a23-453c-b9e0-3a7a6a1be92e

Tizanidine

Orange BookUNIISPLATC M03BX02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133504240
    40 TABLET in 1 BOTTLE (71335-0424-0)
  • ndc11
    7133504241
    30 TABLET in 1 BOTTLE (71335-0424-1)
  • ndc11
    7133504242
    60 TABLET in 1 BOTTLE (71335-0424-2)
  • ndc11
    7133504243
    90 TABLET in 1 BOTTLE (71335-0424-3)
  • ndc11
    7133504244
    120 TABLET in 1 BOTTLE (71335-0424-4)
  • ndc11
    7133504245
    100 TABLET in 1 BOTTLE (71335-0424-5)
  • ndc11
    7133504246
    84 TABLET in 1 BOTTLE (71335-0424-6)
  • ndc11
    7133504247
    28 TABLET in 1 BOTTLE (71335-0424-7)
  • ndc11
    7133504248
    21 TABLET in 1 BOTTLE (71335-0424-8)
  • ndc11
    7133504249
    160 TABLET in 1 BOTTLE (71335-0424-9)

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": "71335-0424_2ea6e19f-4a23-453c-b9e0-3a7a6a1be92e",
  "productndc": "71335-0424",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091283",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine",
  "start_marketing_date": "20130401",
  "active_numerator_strength": "2"
}

Related drugs

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