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 · 11

ndc11
7161079010
10 TABLET in 1 BOTTLE (71610-790-10)
ndc11
7161079015
15 TABLET in 1 BOTTLE (71610-790-15)
ndc11
7161079020
20 TABLET in 1 BOTTLE (71610-790-20)
ndc11
7161079028
28 TABLET in 1 BOTTLE (71610-790-28)
ndc11
7161079030
30 TABLET in 1 BOTTLE (71610-790-30)
ndc11
7161079045
45 TABLET in 1 BOTTLE (71610-790-45)
ndc11
7161079046
56 TABLET in 1 BOTTLE (71610-790-46)
ndc11
7161079053
60 TABLET in 1 BOTTLE (71610-790-53)
ndc11
7161079055
75 TABLET in 1 BOTTLE (71610-790-55)
ndc11
7161079060
90 TABLET in 1 BOTTLE (71610-790-60)
ndc11
7161079070
120 TABLET in 1 BOTTLE (71610-790-70)

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": "71610-790_2528d6db-eb77-3ccc-e063-6294a90a3022",
  "productndc": "71610-790",
  "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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