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United States · US · US:67877-731_541259c3-7b51-4c46-a11c-f199d185ace0

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Orange BookUNIISPLATC N05BA

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN05BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6787773101
    100 CAPSULE in 1 BOTTLE (67877-731-01)
  • ndc11
    6787773105
    500 CAPSULE in 1 BOTTLE (67877-731-05)
  • ndc11
    6787773138
    100 BLISTER PACK in 1 CARTON (67877-731-38) / 10 CAPSULE in 1 BLISTER PACK (67877-731-33)

Annotations

UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
A214065
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": "67877-731_541259c3-7b51-4c46-a11c-f199d185ace0",
  "productndc": "67877-731",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214065",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;2.5MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
  "proprietary_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214065",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide",
  "start_marketing_date": "20210427",
  "active_numerator_strength": "5; 2.5"
}

Related drugs

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