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United States · US · US:71335-2325_3c16209f-1ef5-4738-b6c1-eb3afac50967

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
    7133523250
    112 TABLET in 1 BOTTLE (71335-2325-0)
  • ndc11
    7133523251
    30 TABLET in 1 BOTTLE (71335-2325-1)
  • ndc11
    7133523252
    60 TABLET in 1 BOTTLE (71335-2325-2)
  • ndc11
    7133523253
    90 TABLET in 1 BOTTLE (71335-2325-3)
  • ndc11
    7133523254
    120 TABLET in 1 BOTTLE (71335-2325-4)
  • ndc11
    7133523255
    20 TABLET in 1 BOTTLE (71335-2325-5)
  • ndc11
    7133523256
    45 TABLET in 1 BOTTLE (71335-2325-6)
  • ndc11
    7133523257
    140 TABLET in 1 BOTTLE (71335-2325-7)
  • ndc11
    7133523258
    84 TABLET in 1 BOTTLE (71335-2325-8)
  • ndc11
    7133523259
    28 TABLET in 1 BOTTLE (71335-2325-9)

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": "71335-2325_3c16209f-1ef5-4738-b6c1-eb3afac50967",
  "productndc": "71335-2325",
  "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": "20020703",
  "active_numerator_strength": "4"
}

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