Back to search
🇺🇸

United States · US · US:0641-6045_7c73dbc6-2623-4443-9b05-97dec7a0be2e

Lorazepam

In shortageOrange BookUNIISPLATC N05BA56

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05BA56
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0641604525
    25 VIAL in 1 CARTON (0641-6045-25) / 1 mL in 1 VIAL (0641-6045-01)

Annotations

UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
N018140
APAP
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": "0641-6045_7c73dbc6-2623-4443-9b05-97dec7a0be2e",
  "productndc": "0641-6045",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018140",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "4MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA018140",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lorazepam",
  "start_marketing_date": "19800725",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N05BA56.

Access this data programmatically

Query Lorazepam and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.