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United States · US · US:68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5
Clonazepam
In shortageOrange BookUNIISPLATC N03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11687888401220 TABLET in 1 BOTTLE, PLASTIC (68788-8401-2)
- ndc11687888401330 TABLET in 1 BOTTLE, PLASTIC (68788-8401-3)
- ndc11687888401660 TABLET in 1 BOTTLE, PLASTIC (68788-8401-6)
- ndc11687888401828 TABLET in 1 BOTTLE, PLASTIC (68788-8401-8)
- ndc11687888401990 TABLET in 1 BOTTLE, PLASTIC (68788-8401-9)
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": "68788-8401_f9ccda6a-4c5a-4acf-8a78-cb854f4f14e5",
"productndc": "68788-8401",
"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": "20230321",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N03AE01.
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