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United States · US · US:62559-197_14501e2f-99a6-44c0-ba71-12c12d02888b
Lorazepam
In shortageOrange BookUNIISPLATC N05BA56
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BA56
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116255919701100 TABLET in 1 BOTTLE (62559-197-01)
- ndc116255919705500 TABLET in 1 BOTTLE (62559-197-05)
- ndc1162559197101000 TABLET in 1 BOTTLE (62559-197-10)
Annotations
UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
A077396
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lorazepam Injection
Raw payload (JSON)
{
"unii": {
"unii": "O26FZP769L",
"rxcui": "6470",
"inchikey": "DIWRORZWFLOCLC-UHFFFAOYSA-N",
"display_name": "LORAZEPAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4a50329b-b272-4164-bddf-0d6cea3d7a23": {
"match": "brand_token",
"title": "LORAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "62559-197_14501e2f-99a6-44c0-ba71-12c12d02888b",
"productndc": "62559-197",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077396",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Dec 13, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Dec 13, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Dec 13, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LORAZEPAM",
"shortage_reason": "Lorazepam Injection",
"shortage_status": "current",
"proprietary_name": "Lorazepam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077396",
"marketing_category": "ANDA",
"nonproprietary_name": "Lorazepam",
"start_marketing_date": "20241201",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA56.
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