LEVORPHANOL TARTRATE

Orange BookUNIISPL

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054043825
100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)

Annotations

UNII (FDA Substance ID)

04WQU6T9QI

LEVORPHANOL TARTRATE

RxCUI 153973

Orange Book

A074278

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "04WQU6T9QI",
    "rxcui": "153973",
    "inchikey": "UMZNDVASJKIQCB-QLFXFZCRSA-N",
    "display_name": "LEVORPHANOL TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "759c7040-0be0-4d17-be97-e467e423eaa8": {
      "match": "brand_token",
      "title": "LEVORPHANOL TARTRATE TABLET [SPECGX LLC]",
      "spl_version": "18",
      "published_date": "2026-05-01"
    }
  },
  "productid": "0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5f",
  "productndc": "0054-0438",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jun 18, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Jun 18, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVORPHANOL TARTRATE",
  "proprietary_name": "LEVORPHANOL TARTRATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVORPHANOL TARTRATE",
  "start_marketing_date": "20000331",
  "active_numerator_strength": "2"
}

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