LOREEV XR

In shortageOrange BookUNIISPLATC N05BA56

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN05BA56

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009075920
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-7592-0)

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": "50090-7592_797bc295-d908-4740-b496-c87e19b0eca4",
  "productndc": "50090-7592",
  "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": "20220301",
  "active_numerator_strength": "1.5"
}

Related drugs

Other records sharing ATC code N05BA56.

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