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United States · US · US:67046-1601_40074e64-23a7-50b1-e063-6294a90a92c6

Clorazepate Dipotassium

Orange BookUNIISPLATC N05BA

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

Identification

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

Packs · 1

  • ndc11
    6704616013
    30 TABLET in 1 BLISTER PACK (67046-1601-3)

Annotations

UNII (FDA Substance ID)
63FN7G03XY
CLORAZEPATE DIPOTASSIUM
RxCUI 2607
Orange Book
A075731
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "63FN7G03XY",
    "rxcui": "2607",
    "inchikey": "QCHSEDTUUKDTIG-UHFFFAOYSA-L",
    "display_name": "CLORAZEPATE DIPOTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "919cbd07-f587-4005-acff-26213dd1d1fb": {
      "match": "brand_token",
      "title": "CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA LLC]",
      "spl_version": "5",
      "published_date": "2026-03-26"
    }
  },
  "productid": "67046-1601_40074e64-23a7-50b1-e063-6294a90a92c6",
  "productndc": "67046-1601",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075731",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 27, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Apr 27, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG",
        "product_no": "003",
        "approval_date": "Apr 27, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLORAZEPATE DIPOTASSIUM",
  "proprietary_name": "Clorazepate Dipotassium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075731",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clorazepate Dipotassium",
  "start_marketing_date": "20250930",
  "active_numerator_strength": "7.5"
}

Related drugs

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