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United States · US · US:64980-628_b47aeb6e-aa7a-469b-a709-15df0e99ea79
Lorazepam
In shortageOrange BookUNIISPLATC N05BA56
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN05BA56
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116498062801100 TABLET in 1 BOTTLE (64980-628-01)
- ndc1164980628101000 TABLET in 1 BOTTLE (64980-628-10)
- ndc116498062850500 TABLET in 1 BOTTLE (64980-628-50)
Annotations
UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
A218597
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": "64980-628_b47aeb6e-aa7a-469b-a709-15df0e99ea79",
"productndc": "64980-628",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Jul 24, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Jul 24, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Jul 24, 2025"
}
],
"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": "ANDA218597",
"marketing_category": "ANDA",
"nonproprietary_name": "Lorazepam",
"start_marketing_date": "20250724",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05BA56.
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