OXYMORPHONE HYDROCHLORIDE

Orange BookUNIISPLATC N02AA11

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN02AA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362919261
100 TABLET in 1 BOTTLE (63629-1926-1)

Annotations

UNII (FDA Substance ID)

5Y2EI94NBC

OXYMORPHONE HYDROCHLORIDE

RxCUI 82064

Orange Book

A210175

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": "63629-1926_c58a9e13-1792-4569-a677-28d9aaf0c9f0",
  "productndc": "63629-1926",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210175",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 2, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 2, 2018"
      }
    ],
    "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": "ANDA210175",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXYMORPHONE HYDROCHLORIDE",
  "start_marketing_date": "20180301",
  "active_numerator_strength": "5"
}

Related drugs

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