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United States · US · US:13107-319_5da093d0-dc77-4240-97f1-d1e0ccc622ff

CLORAZEPATE DIPOTASSIUM

Orange BookUNIISPLATC N05BA

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

Identification

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

Packs · 2

  • ndc11
    1310731901
    100 TABLET in 1 BOTTLE (13107-319-01)
  • ndc11
    1310731905
    500 TABLET in 1 BOTTLE, PLASTIC (13107-319-05)

Annotations

UNII (FDA Substance ID)
63FN7G03XY
CLORAZEPATE DIPOTASSIUM
RxCUI 2607
Orange Book
A071858
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": "13107-319_5da093d0-dc77-4240-97f1-d1e0ccc622ff",
  "productndc": "13107-319",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071858",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jul 17, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG",
        "product_no": "002",
        "approval_date": "Jul 17, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Jul 17, 1987"
      }
    ],
    "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": "ANDA071858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CLORAZEPATE DIPOTASSIUM",
  "start_marketing_date": "19870717",
  "active_numerator_strength": "3.75"
}

Related drugs

Other records sharing ATC code N05BA.

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