Levorphanol Tartrate

Orange BookUNIISPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362920931
100 TABLET in 1 BOTTLE (63629-2093-1)

Annotations

UNII (FDA Substance ID)

04WQU6T9QI

LEVORPHANOL TARTRATE

RxCUI 153973

Orange Book

A213479

BXBXBX

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": "63629-2093_46b0156b-828d-4997-bc71-e4e5471b9883",
  "productndc": "63629-2093",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213479",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Jan 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Jul 20, 2021"
      }
    ],
    "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": "ANDA213479",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levorphanol Tartrate",
  "start_marketing_date": "20190520",
  "active_numerator_strength": "2"
}

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