LOREEV XR

In shortageOrange BookUNIISPLATC N05BA56

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAlmatica Pharma LLC

CountryUS (United States)

ATC codeN05BA56

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5242765830
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30)

Annotations

UNII (FDA Substance ID)

O26FZP769L

LORAZEPAM

RxCUI 6470

Orange Book

N214826

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": {
    "227734c1-bf01-9607-73ea-5a1f38a89bd9": {
      "match": "brand_token",
      "title": "LOREEV XR (LORAZEPAM) CAPSULE, EXTENDED RELEASE [ALMATICA PHARMA LLC]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "52427-658_1ce5f319-4e44-ae8e-b6be-ecf54a0d345a",
  "productndc": "52427-658",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214826",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 27, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Aug 27, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "004",
        "approval_date": "Feb 16, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LORAZEPAM",
  "shortage_reason": "Lorazepam Injection",
  "shortage_status": "current",
  "proprietary_name": "LOREEV XR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214826",
  "marketing_category": "NDA",
  "nonproprietary_name": "lorazepam",
  "start_marketing_date": "20210831",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05BA56.

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