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United States · US · US:71335-0914_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
    7133509140
    112 TABLET in 1 BOTTLE (71335-0914-0)
  • ndc11
    7133509141
    30 TABLET in 1 BOTTLE (71335-0914-1)
  • ndc11
    7133509142
    60 TABLET in 1 BOTTLE (71335-0914-2)
  • ndc11
    7133509143
    90 TABLET in 1 BOTTLE (71335-0914-3)
  • ndc11
    7133509144
    120 TABLET in 1 BOTTLE (71335-0914-4)
  • ndc11
    7133509145
    20 TABLET in 1 BOTTLE (71335-0914-5)
  • ndc11
    7133509146
    45 TABLET in 1 BOTTLE (71335-0914-6)
  • ndc11
    7133509147
    140 TABLET in 1 BOTTLE (71335-0914-7)
  • ndc11
    7133509148
    84 TABLET in 1 BOTTLE (71335-0914-8)
  • ndc11
    7133509149
    28 TABLET in 1 BOTTLE (71335-0914-9)

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": "71335-0914_2ea6e19f-4a23-453c-b9e0-3a7a6a1be92e",
  "productndc": "71335-0914",
  "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": "4"
}

Related drugs

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