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United States · US · US:70515-594_3468e009-cfd1-f217-e063-6294a90a1429

Zanaflex

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeM03BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051559415
    150 TABLET in 1 BOTTLE (70515-594-15)

Annotations

UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
N020397
AB
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": {
    "60c27d35-7349-4fc6-86ad-70fffdbe3e08": {
      "match": "brand_token",
      "title": "ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.]",
      "spl_version": "2",
      "published_date": "2026-01-05"
    }
  },
  "productid": "70515-594_3468e009-cfd1-f217-e063-6294a90a1429",
  "productndc": "70515-594",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020397",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Nov 27, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 4, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIZANIDINE HYDROCHLORIDE",
  "proprietary_name": "Zanaflex",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020397",
  "marketing_category": "NDA",
  "nonproprietary_name": "tizanidine hydrochloride",
  "start_marketing_date": "20180801",
  "active_numerator_strength": "4"
}

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