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United States · US · US:61269-620_63cfdab9-fb3d-4c2b-bf88-8ba841dba839

Klonopin

In shortageOrange BookUNIISPLATC N03AE01

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

Identification

ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeN03AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6126962010
    100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10)

Annotations

UNII (FDA Substance ID)
5PE9FDE8GB
CLONAZEPAM
RxCUI 2598
Orange Book
N017533
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": {
    "cfa0d79a-843c-4b88-95a1-e9511d649ca1": {
      "match": "brand_token",
      "title": "KLONOPIN (CLONAZEPAM) TABLET [H2-PHARMA, LLC]",
      "spl_version": "6",
      "published_date": "2025-12-02"
    }
  },
  "productid": "61269-620_63cfdab9-fb3d-4c2b-bf88-8ba841dba839",
  "productndc": "61269-620",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017533",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Apr 9, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Apr 9, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONAZEPAM",
  "shortage_reason": "Clonazepam Tablet",
  "shortage_status": "current",
  "proprietary_name": "Klonopin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017533",
  "marketing_category": "NDA",
  "nonproprietary_name": "Clonazepam",
  "start_marketing_date": "19750602",
  "active_numerator_strength": "2"
}

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