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United States · US · US:43547-407_dc17b9d4-2890-4f6c-8476-daa39d0cbc9c

Clonazepam

In shortageOrange BookUNIISPLATC N03AE01

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

Identification

ManufacturerSolco Healthcare LLC
CountryUS (United States)
ATC codeN03AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4354740710
    100 TABLET in 1 BOTTLE, PLASTIC (43547-407-10)
  • ndc11
    4354740711
    1000 TABLET in 1 BOTTLE, PLASTIC (43547-407-11)
  • ndc11
    4354740750
    500 TABLET in 1 BOTTLE, PLASTIC (43547-407-50)

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": "43547-407_dc17b9d4-2890-4f6c-8476-daa39d0cbc9c",
  "productndc": "43547-407",
  "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": "20180215",
  "active_numerator_strength": "1"
}

Related drugs

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