Zanaflex

Orange BookUNIISPLATC M03BX02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
7051560615
150 CAPSULE in 1 BOTTLE (70515-606-15)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

N021447

ABABAB

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": "70515-606_3468e009-cfd1-f217-e063-6294a90a1429",
  "productndc": "70515-606",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021447",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Aug 29, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Aug 29, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Aug 29, 2002"
      }
    ],
    "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": "NDA021447",
  "marketing_category": "NDA",
  "nonproprietary_name": "tizanidine hydrochloride",
  "start_marketing_date": "20180801",
  "active_numerator_strength": "6"
}

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