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 · 10

ndc11
7133518430
100 TABLET in 1 BOTTLE, PLASTIC (71335-1843-0)
ndc11
7133518431
20 TABLET in 1 BOTTLE, PLASTIC (71335-1843-1)
ndc11
7133518432
30 TABLET in 1 BOTTLE, PLASTIC (71335-1843-2)
ndc11
7133518433
60 TABLET in 1 BOTTLE, PLASTIC (71335-1843-3)
ndc11
7133518434
90 TABLET in 1 BOTTLE, PLASTIC (71335-1843-4)
ndc11
7133518435
120 TABLET in 1 BOTTLE, PLASTIC (71335-1843-5)
ndc11
7133518436
180 TABLET in 1 BOTTLE, PLASTIC (71335-1843-6)
ndc11
7133518437
84 TABLET in 1 BOTTLE, PLASTIC (71335-1843-7)
ndc11
7133518438
28 TABLET in 1 BOTTLE, PLASTIC (71335-1843-8)
ndc11
7133518439
56 TABLET in 1 BOTTLE, PLASTIC (71335-1843-9)

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": "71335-1843_de60045d-eb54-4f61-ad0a-1deb16c537b2",
  "productndc": "71335-1843",
  "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"
}

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