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United States · US · US:63629-3209_82084f4e-00d0-c298-c13a-88a6c0860b02

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
    6362932090
    40 TABLET in 1 BOTTLE (63629-3209-0)
  • ndc11
    6362932091
    30 TABLET in 1 BOTTLE (63629-3209-1)
  • ndc11
    6362932092
    60 TABLET in 1 BOTTLE (63629-3209-2)
  • ndc11
    6362932093
    90 TABLET in 1 BOTTLE (63629-3209-3)
  • ndc11
    6362932094
    120 TABLET in 1 BOTTLE (63629-3209-4)
  • ndc11
    6362932095
    100 TABLET in 1 BOTTLE (63629-3209-5)
  • ndc11
    6362932096
    84 TABLET in 1 BOTTLE (63629-3209-6)
  • ndc11
    6362932097
    28 TABLET in 1 BOTTLE (63629-3209-7)
  • ndc11
    6362932098
    21 TABLET in 1 BOTTLE (63629-3209-8)
  • ndc11
    6362932099
    160 TABLET in 1 BOTTLE (63629-3209-9)

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": "63629-3209_82084f4e-00d0-c298-c13a-88a6c0860b02",
  "productndc": "63629-3209",
  "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": "2"
}

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