Clonazepam

In shortageOrange BookUNIISPLATC N03AE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeN03AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213577190
90 TABLET in 1 BOTTLE (62135-771-90)

Annotations

UNII (FDA Substance ID)

5PE9FDE8GB

CLONAZEPAM

RxCUI 2598

Orange Book

A074925

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": "62135-771_09184e1a-1808-d656-e063-6294a90aa6f8",
  "productndc": "62135-771",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074925",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Sep 30, 1997"
      }
    ],
    "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": "ANDA074925",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonazepam",
  "start_marketing_date": "19970930",
  "active_numerator_strength": "2"
}

Related drugs

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