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United States · US · US:43063-046_3edd1001-c580-bf18-e063-6394a90a3c31

Chlordiazepoxide Hydrochloride

Orange BookUNIISPLATC N05BA02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    4306304603
    3 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03)
  • ndc11
    4306304606
    6 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-06)
  • ndc11
    4306304612
    12 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-12)
  • ndc11
    4306304615
    15 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-15)
  • ndc11
    4306304619
    19 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-19)
  • ndc11
    4306304624
    24 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-24)

Annotations

UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
A084769
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": "43063-046_3edd1001-c580-bf18-e063-6394a90a3c31",
  "productndc": "43063-046",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "084769",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "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": "ANDA084769",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlordiazepoxide Hydrochloride",
  "start_marketing_date": "19760701",
  "active_numerator_strength": "25"
}

Related drugs

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