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United States · US · US:65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0

Lorazepam

In shortageOrange BookUNIISPLATC N05BA56

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05BA56
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6516268784
    30 mL in 1 BOTTLE, DROPPER (65162-687-84)

Annotations

UNII (FDA Substance ID)
O26FZP769L
LORAZEPAM
RxCUI 6470
Orange Book
A091383
AA
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": "65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0",
  "productndc": "65162-687",
  "dosage_form": "CONCENTRATE",
  "orange_book": {
    "appl_no": "091383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Dec 23, 2009"
      }
    ],
    "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": "ANDA091383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lorazepam",
  "start_marketing_date": "20100201",
  "active_numerator_strength": "2"
}

Related drugs

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