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United States · US · US:0254-2053_fdae58ba-f86a-47bc-af18-a80d5cfa1107

Chlorzoxazone

Orange BookUNIISPLATC M03BB53

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeM03BB53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0254205301
    100 TABLET in 1 BOTTLE (0254-2053-01)

Annotations

UNII (FDA Substance ID)
H0DE420U8G
CHLORZOXAZONE
RxCUI 2410
Orange Book
A212743
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H0DE420U8G",
    "rxcui": "2410",
    "inchikey": "TZFWDZFKRBELIQ-UHFFFAOYSA-N",
    "display_name": "CHLORZOXAZONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6c77ca6b-fda6-43ab-8179-3e0bde6aa65f": {
      "match": "brand_token",
      "title": "CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-04-14"
    }
  },
  "productid": "0254-2053_fdae58ba-f86a-47bc-af18-a80d5cfa1107",
  "productndc": "0254-2053",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212743",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "001",
        "approval_date": "Nov 2, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Apr 29, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORZOXAZONE",
  "proprietary_name": "Chlorzoxazone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212743",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlorzoxazone",
  "start_marketing_date": "20210617",
  "active_numerator_strength": "375"
}

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