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United States · US · US:67877-658_fe56fe48-c21a-42ca-b82e-54c8ea178431

Clobazam

Orange BookUNIISPLATC N05BA09

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

Identification

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

Packs · 1

  • ndc11
    6787765861
    1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
A213039
AB
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": "67877-658_fe56fe48-c21a-42ca-b82e-54c8ea178431",
  "productndc": "67877-658",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "213039",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG/ML",
        "product_no": "001",
        "approval_date": "May 6, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBAZAM",
  "proprietary_name": "Clobazam",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213039",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobazam",
  "start_marketing_date": "20210507",
  "active_numerator_strength": "2.5"
}

Related drugs

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