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United States · US · US:0187-4100_98fd8b52-2fc3-4540-8333-75b5c853aee2

Librax

Orange BookUNIIATC N05BA

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

Identification

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

Packs · 1

  • ndc11
    0187410010
    100 CAPSULE in 1 BOTTLE (0187-4100-10)

Annotations

UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
N012750
AB
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",
  "productid": "0187-4100_98fd8b52-2fc3-4540-8333-75b5c853aee2",
  "productndc": "0187-4100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "012750",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;2.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
  "proprietary_name": "Librax",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA012750",
  "marketing_category": "NDA",
  "nonproprietary_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide",
  "start_marketing_date": "19660901",
  "active_numerator_strength": "5; 2.5"
}

Related drugs

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