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United States · US · US:70518-2507_4e012086-11e6-3569-e063-6294a90a742c
Clonazepam
In shortageOrange BookUNIISPLATC N03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117051825070100 POUCH in 1 BOX (70518-2507-0) / 1 TABLET in 1 POUCH (70518-2507-1)
- ndc11705182507430 TABLET in 1 BLISTER PACK (70518-2507-4)
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": "70518-2507_4e012086-11e6-3569-e063-6294a90a742c",
"productndc": "70518-2507",
"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": "20191226",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code N03AE01.
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