CHLORDIAZEPOXIDE HYDROCHLORIDE

Orange BookUNIISPLATC N05BA02

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

Identification

ManufacturerEpic Pharma, LLC

CountryUS (United States)

ATC codeN05BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4280656401
100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-564-01)

Annotations

UNII (FDA Substance ID)

MFM6K1XWDK

CHLORDIAZEPOXIDE HYDROCHLORIDE

RxCUI 203173

Orange Book

A085461

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MFM6K1XWDK",
    "rxcui": "203173",
    "inchikey": "DMLFJMQTNDSRFU-UHFFFAOYSA-N",
    "display_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "511264f5-024b-350a-e063-6394a90a51e9": {
      "match": "brand_token",
      "title": "CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [COUPER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-07"
    }
  },
  "productid": "42806-564_d7a3306e-01d4-4966-a473-62136d81f959",
  "productndc": "42806-564",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "085461",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
  "proprietary_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA085461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
  "start_marketing_date": "20211109",
  "active_numerator_strength": "5"
}

Related drugs

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