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United States · US · US:16729-138_0e1e7f41-f78b-27cf-e063-6394a90a1ae0
Clonazepam
In shortageOrange BookUNIISPLATC N03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeN03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111672913800100 TABLET in 1 BOTTLE, PLASTIC (16729-138-00)
- ndc111672913816500 TABLET in 1 BOTTLE, PLASTIC (16729-138-16)
Annotations
UNII (FDA Substance ID)
5PE9FDE8GB
CLONAZEPAM
RxCUI 2598
Orange Book
A077147
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": "16729-138_0e1e7f41-f78b-27cf-e063-6394a90a1ae0",
"productndc": "16729-138",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077147",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "May 2, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "May 2, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "May 2, 2005"
}
],
"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": "ANDA077147",
"marketing_category": "ANDA",
"nonproprietary_name": "clonazepam",
"start_marketing_date": "20110603",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N03AE01.
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