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United States · US · US:13107-103_6c5c7596-0b2c-435f-a619-706b4424370d

Oxymorphone Hydrochloride

Orange BookUNIISPLATC N02AA11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN02AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1310710301
    100 TABLET in 1 BOTTLE (13107-103-01)
  • ndc11
    1310710330
    30 TABLET in 1 BOTTLE (13107-103-30)
  • ndc11
    1310710399
    1000 TABLET in 1 BOTTLE (13107-103-99)

Annotations

UNII (FDA Substance ID)
5Y2EI94NBC
OXYMORPHONE HYDROCHLORIDE
RxCUI 82064
Orange Book
A204459
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": "13107-103_6c5c7596-0b2c-435f-a619-706b4424370d",
  "productndc": "13107-103",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204459",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2016"
      }
    ],
    "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": "ANDA204459",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxymorphone Hydrochloride",
  "start_marketing_date": "20160426",
  "active_numerator_strength": "5"
}

Related drugs

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