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United States · US · US:71335-1799_eee9769d-c60c-477c-bad4-01b3acb68abc

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
    7133517990
    40 TABLET in 1 BOTTLE (71335-1799-0)
  • ndc11
    7133517991
    30 TABLET in 1 BOTTLE (71335-1799-1)
  • ndc11
    7133517992
    60 TABLET in 1 BOTTLE (71335-1799-2)
  • ndc11
    7133517993
    90 TABLET in 1 BOTTLE (71335-1799-3)
  • ndc11
    7133517994
    120 TABLET in 1 BOTTLE (71335-1799-4)
  • ndc11
    7133517995
    100 TABLET in 1 BOTTLE (71335-1799-5)
  • ndc11
    7133517996
    84 TABLET in 1 BOTTLE (71335-1799-6)
  • ndc11
    7133517997
    28 TABLET in 1 BOTTLE (71335-1799-7)
  • ndc11
    7133517998
    21 TABLET in 1 BOTTLE (71335-1799-8)
  • ndc11
    7133517999
    160 TABLET in 1 BOTTLE (71335-1799-9)

Annotations

UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A076416
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": "71335-1799_eee9769d-c60c-477c-bad4-01b3acb68abc",
  "productndc": "71335-1799",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076416",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Sep 29, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Sep 29, 2003"
      }
    ],
    "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": "ANDA076416",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine",
  "start_marketing_date": "20031211",
  "active_numerator_strength": "2"
}

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