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United States · US · US:68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5

Clonazepam

In shortageOrange BookUNIISPLATC N03AE01

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6878884012
    20 TABLET in 1 BOTTLE, PLASTIC (68788-8401-2)
  • ndc11
    6878884013
    30 TABLET in 1 BOTTLE, PLASTIC (68788-8401-3)
  • ndc11
    6878884016
    60 TABLET in 1 BOTTLE, PLASTIC (68788-8401-6)
  • ndc11
    6878884018
    28 TABLET in 1 BOTTLE, PLASTIC (68788-8401-8)
  • ndc11
    6878884019
    90 TABLET in 1 BOTTLE, PLASTIC (68788-8401-9)

Annotations

UNII (FDA Substance ID)
5PE9FDE8GB
CLONAZEPAM
RxCUI 2598
Orange Book
A077856
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clonazepam Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "5PE9FDE8GB",
    "rxcui": "2598",
    "inchikey": "DGBIGWXXNGSACT-UHFFFAOYSA-N",
    "display_name": "CLONAZEPAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "19fc756c-72fe-4504-beaa-4fa2235af18c": {
      "match": "brand_token",
      "title": "CLONAZEPAM TABLET, ORALLY DISINTEGRATING [ADVAGEN PHARMA LTD]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5",
  "productndc": "68788-8401",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077856",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Jun 28, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONAZEPAM",
  "shortage_reason": "Clonazepam Tablet",
  "shortage_status": "current",
  "proprietary_name": "Clonazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077856",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clonazepam",
  "start_marketing_date": "20230321",
  "active_numerator_strength": "1"
}

Related drugs

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