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United States · US · US:70518-4364_4986f0f6-a218-6af3-e063-6394a90a34d3

CHLORZOXAZONE

Orange BookUNIISPLATC M03BB53

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeM03BB53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051843640
    90 TABLET in 1 BOTTLE, PLASTIC (70518-4364-0)
  • ndc11
    7051843641
    60 TABLET in 1 BOTTLE, PLASTIC (70518-4364-1)

Annotations

UNII (FDA Substance ID)
H0DE420U8G
CHLORZOXAZONE
RxCUI 2410
Orange Book
A089853
AAABAB
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": "70518-4364_4986f0f6-a218-6af3-e063-6394a90a34d3",
  "productndc": "70518-4364",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "089853",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "May 4, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Aug 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORZOXAZONE",
  "proprietary_name": "CHLORZOXAZONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA089853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CHLORZOXAZONE",
  "start_marketing_date": "20250618",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code M03BB53.

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