🇺🇸
United States · US · US:61269-620_63cfdab9-fb3d-4c2b-bf88-8ba841dba839
Klonopin
In shortageOrange BookUNIISPLATC N03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeN03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116126962010100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10)
Annotations
UNII (FDA Substance ID)
5PE9FDE8GB
CLONAZEPAM
RxCUI 2598
Orange Book
N017533
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": {
"cfa0d79a-843c-4b88-95a1-e9511d649ca1": {
"match": "brand_token",
"title": "KLONOPIN (CLONAZEPAM) TABLET [H2-PHARMA, LLC]",
"spl_version": "6",
"published_date": "2025-12-02"
}
},
"productid": "61269-620_63cfdab9-fb3d-4c2b-bf88-8ba841dba839",
"productndc": "61269-620",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017533",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "005",
"approval_date": "Apr 9, 1997"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "006",
"approval_date": "Apr 9, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLONAZEPAM",
"shortage_reason": "Clonazepam Tablet",
"shortage_status": "current",
"proprietary_name": "Klonopin",
"active_ingred_unit": "mg/1",
"application_number": "NDA017533",
"marketing_category": "NDA",
"nonproprietary_name": "Clonazepam",
"start_marketing_date": "19750602",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N03AE01.
Access this data programmatically
Query Klonopin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.