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United States · US · US:46708-744_398931c6-4954-4bbc-8b63-ea382e5864fc

Chlordiazepoxide hydrochloride and clidinium bromide

Orange BookUNIISPLATC N05BA

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

Identification

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

Packs · 2

  • ndc11
    4670874431
    100 CAPSULE in 1 BOTTLE (46708-744-31)
  • ndc11
    4670874491
    1000 CAPSULE in 1 BOTTLE (46708-744-91)

Annotations

UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
A216969
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": "46708-744_398931c6-4954-4bbc-8b63-ea382e5864fc",
  "productndc": "46708-744",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216969",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;2.5MG",
        "product_no": "001",
        "approval_date": "Sep 15, 2023"
      }
    ],
    "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": "ANDA216969",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlordiazepoxide hydrochloride and clidinium bromide",
  "start_marketing_date": "20231004",
  "active_numerator_strength": "5; 2.5"
}

Related drugs

Other records sharing ATC code N05BA.

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