Oxymorphone hydrochloride

Orange BookUNIISPLATC N02AA11

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN02AA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6489669901
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-699-01)
ndc11
6489669903
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-699-03)
ndc11
6489669908
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-699-08)
ndc11
6489669913
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-699-13)

Annotations

UNII (FDA Substance ID)

5Y2EI94NBC

OXYMORPHONE HYDROCHLORIDE

RxCUI 82064

Orange Book

A079087

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": "64896-699_4f08b804-ef2d-4c9b-8553-c2bc7fa1fd71",
  "productndc": "64896-699",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "079087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 14, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jun 14, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Jun 14, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Jul 22, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "40MG",
        "product_no": "007",
        "approval_date": "Jun 14, 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": "ANDA079087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxymorphone hydrochloride",
  "start_marketing_date": "20130102",
  "active_numerator_strength": "20"
}

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