Oxymorphone Hydrochloride

Orange BookUNIISPLATC N02AA11

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02AA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054028325
100 TABLET in 1 BOTTLE (0054-0283-25)

Annotations

UNII (FDA Substance ID)

5Y2EI94NBC

OXYMORPHONE HYDROCHLORIDE

RxCUI 82064

Orange Book

A090964

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5Y2EI94NBC",
    "rxcui": "82064",
    "inchikey": "BCGJBQBWUGVESK-KCTCKCTRSA-N",
    "display_name": "OXYMORPHONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b": {
      "match": "brand_token",
      "title": "OXYMORPHONE HYDROCHLORIDE TABLET [KVK-TECH, INC.]",
      "spl_version": "17",
      "published_date": "2026-02-02"
    }
  },
  "productid": "0054-0283_74519e3e-078f-42ea-882e-1df0eb0eaaee",
  "productndc": "0054-0283",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090964",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 27, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYMORPHONE HYDROCHLORIDE",
  "proprietary_name": "Oxymorphone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090964",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxymorphone hydrochloride",
  "start_marketing_date": "20100927",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N02AA11.

Access this data programmatically

Query Oxymorphone Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs