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United States · US · US:42571-381_fa3753a6-a410-6ae8-e053-6394a90a0106

CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE

Orange BookUNIISPLATC N05BA

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN05BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4257138101
    100 CAPSULE in 1 BOTTLE (42571-381-01)

Annotations

UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
A215835
AB
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": "42571-381_fa3753a6-a410-6ae8-e053-6394a90a0106",
  "productndc": "42571-381",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215835",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;2.5MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
  "proprietary_name": "CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA215835",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "5; 2.5"
}

Related drugs

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