Lorazepam

In shortageOrange BookUNIISPLATC N05BA56

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

Identification

ManufacturerSUN PHARMACEUTICAL INDUSTRIES INC

CountryUS (United States)

ATC codeN05BA56

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6330477301
100 TABLET in 1 BOTTLE (63304-773-01)
ndc11
6330477305
500 TABLET in 1 BOTTLE (63304-773-05)
ndc11
6330477310
1000 TABLET in 1 BOTTLE (63304-773-10)
ndc11
6330477390
90 TABLET in 1 BOTTLE (63304-773-90)

Annotations

UNII (FDA Substance ID)

O26FZP769L

LORAZEPAM

RxCUI 6470

Orange Book

A076045

ABABAB

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": "63304-773_b8fbb599-96d9-4866-908d-d8be424e5ee3",
  "productndc": "63304-773",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076045",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2001"
      }
    ],
    "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/1",
  "application_number": "ANDA076045",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lorazepam",
  "start_marketing_date": "20230625",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05BA56.

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