Clonazepam

In shortageOrange BookUNIISPLATC N03AE01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN03AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133525091
20 TABLET in 1 BOTTLE (71335-2509-1)
ndc11
7133525092
30 TABLET in 1 BOTTLE (71335-2509-2)
ndc11
7133525093
60 TABLET in 1 BOTTLE (71335-2509-3)
ndc11
7133525094
90 TABLET in 1 BOTTLE (71335-2509-4)
ndc11
7133525095
120 TABLET in 1 BOTTLE (71335-2509-5)
ndc11
7133525096
56 TABLET in 1 BOTTLE (71335-2509-6)
ndc11
7133525097
28 TABLET in 1 BOTTLE (71335-2509-7)
ndc11
7133525098
100 TABLET in 1 BOTTLE (71335-2509-8)
ndc11
7133525099
45 TABLET in 1 BOTTLE (71335-2509-9)

Annotations

UNII (FDA Substance ID)

5PE9FDE8GB

CLONAZEPAM

RxCUI 2598

Orange Book

A075468

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": "71335-2509_fafdf6e5-7b28-4cff-83ae-0a65450a8554",
  "productndc": "71335-2509",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075468",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 6, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Oct 6, 2000"
      }
    ],
    "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": "ANDA075468",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonazepam",
  "start_marketing_date": "20220414",
  "active_numerator_strength": ".5"
}

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