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United States · US · US:13107-084_67012944-0947-4e64-adab-869993f2f709
LORAZEPAM
In shortageOrange BookUNIISPLATC N05BA56
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurolife Pharma LLC
CountryUS (United States)
ATC codeN05BA56
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111310708401100 TABLET in 1 BOTTLE (13107-084-01)
- ndc111310708405500 TABLET in 1 BOTTLE (13107-084-05)
- ndc11131070841010 TABLET in 1 BOTTLE (13107-084-10)
- ndc1113107084991000 TABLET in 1 BOTTLE (13107-084-99)
Annotations
UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
A203572
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": "13107-084_67012944-0947-4e64-adab-869993f2f709",
"productndc": "13107-084",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203572",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Dec 22, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Dec 22, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Dec 22, 2017"
}
],
"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": "ANDA203572",
"marketing_category": "ANDA",
"nonproprietary_name": "LORAZEPAM",
"start_marketing_date": "20210201",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05BA56.
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