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United States · US · US:68180-157_ce8d2e9b-0cf3-4206-9523-6f0df27953b8

Clobazam

Orange BookUNIISPLATC N05BA09

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6818015701
    1 BOTTLE in 1 CARTON (68180-157-01) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2MRO291B4U
CLOBAZAM
RxCUI 21241
Orange Book
A210545
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": "68180-157_ce8d2e9b-0cf3-4206-9523-6f0df27953b8",
  "productndc": "68180-157",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210545",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Dec 14, 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": "ANDA210545",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clobazam",
  "start_marketing_date": "20190508",
  "active_numerator_strength": "10"
}

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