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United States · US · US:0832-0580_1e02d082-c325-6bd1-e063-6294a90a14ac

Clobazam

Orange BookUNIISPLATC N05BA09

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN05BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0832058011
    100 TABLET in 1 BOTTLE (0832-0580-11)

Annotations

UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
A209687
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2MRO291B4U",
    "rxcui": "21241",
    "inchikey": "CXOXHMZGEKVPMT-UHFFFAOYSA-N",
    "display_name": "CLOBAZAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "721dde68-db83-4dad-8649-8046cb455372": {
      "match": "brand_token",
      "title": "CLOBAZAM (CLOBAZAM) TABLET [MICRO LABS LIMITED]",
      "spl_version": "10",
      "published_date": "2026-05-04"
    }
  },
  "productid": "0832-0580_1e02d082-c325-6bd1-e063-6294a90a14ac",
  "productndc": "0832-0580",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209687",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 22, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 22, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBAZAM",
  "proprietary_name": "Clobazam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209687",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobazam",
  "start_marketing_date": "20181022",
  "active_numerator_strength": "10"
}

Related drugs

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