Clonazepam

In shortageOrange BookUNIISPLATC N03AE01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN03AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 12

ndc11
6754452910
10 TABLET in 1 BOTTLE (67544-529-10)
ndc11
6754452915
15 TABLET in 1 BOTTLE (67544-529-15)
ndc11
6754452928
28 TABLET in 1 BOTTLE (67544-529-28)
ndc11
6754452930
30 TABLET in 1 BOTTLE (67544-529-30)
ndc11
6754452945
45 TABLET in 1 BOTTLE (67544-529-45)
ndc11
6754452953
60 TABLET in 1 BOTTLE (67544-529-53)
ndc11
6754452954
84 TABLET in 1 BOTTLE (67544-529-54)
ndc11
6754452955
75 TABLET in 1 BOTTLE (67544-529-55)
ndc11
6754452960
90 TABLET in 1 BOTTLE (67544-529-60)
ndc11
6754452970
120 TABLET in 1 BOTTLE (67544-529-70)
ndc11
6754452975
150 TABLET in 1 BOTTLE (67544-529-75)
ndc11
6754452980
180 TABLET in 1 BOTTLE (67544-529-80)

Annotations

UNII (FDA Substance ID)

5PE9FDE8GB

CLONAZEPAM

RxCUI 2598

Orange Book

A074569

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": "67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834",
  "productndc": "67544-529",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 10, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Sep 10, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Sep 10, 1996"
      }
    ],
    "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": "ANDA074569",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonazepam",
  "start_marketing_date": "19960918",
  "active_numerator_strength": ".5"
}

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