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United States · US · US:65219-368_5cd2d0d8-9639-4e96-aafd-4991ad35fabc
Lorazepam
In shortageOrange BookUNIISPLATC N05BA56
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN05BA56
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11652193680225 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01)
Annotations
UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
A217598
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "65219-368_5cd2d0d8-9639-4e96-aafd-4991ad35fabc",
"productndc": "65219-368",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217598",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Nov 18, 2024"
}
],
"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/mL",
"application_number": "ANDA217598",
"marketing_category": "ANDA",
"nonproprietary_name": "Lorazepam",
"start_marketing_date": "20241213",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05BA56.
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