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United States · US · US:42571-316_50d350cb-6640-b3c2-e063-6394a90a397b

Clobazam

Orange BookUNIISPLATC N05BA09

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN05BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4257131601
    100 TABLET in 1 BOTTLE (42571-316-01)
  • ndc11
    4257131611
    100 BLISTER PACK in 1 CARTON (42571-316-11) / 10 TABLET in 1 BLISTER PACK (42571-316-32)
  • ndc11
    4257131630
    30 TABLET in 1 BOTTLE (42571-316-30)
  • ndc11
    4257131690
    90 TABLET in 1 BOTTLE (42571-316-90)
  • ndc11
    4257131691
    100 BLISTER PACK in 1 CARTON (42571-316-91) / 10 TABLET in 1 BLISTER PACK (42571-316-20)

Annotations

UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
A211711
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": "42571-316_50d350cb-6640-b3c2-e063-6394a90a397b",
  "productndc": "42571-316",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211711",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBAZAM",
  "proprietary_name": "Clobazam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211711",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobazam",
  "start_marketing_date": "20190402",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N05BA09.

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