Oxymorphone hydrochloride

Orange BookUNIISPLATC N02AA11

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeN02AA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0115131601
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-01)
ndc11
0115131603
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-03)
ndc11
0115131608
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-08)
ndc11
0115131613
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-13)

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": "0115-1316_a8dc6624-df1e-4e5a-b445-9541658e3430",
  "productndc": "0115-1316",
  "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": "15"
}

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