Oxycodone Hydrochloride Oral Solution

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerAurolife Pharma, LLC

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1310726158
1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

A212429

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Oxycodone Hydrochloride Oral Solution

Raw payload (JSON)

{
  "unii": {
    "unii": "C1ENJ2TE6C",
    "rxcui": "82063",
    "inchikey": "MUZQPDBAOYKNLO-RKXJKUSZSA-N",
    "display_name": "OXYCODONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "27124cdf-a3e8-474c-9c1e-6fa48f6ddc05": {
      "match": "brand_token",
      "title": "OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-06-01"
    }
  },
  "productid": "13107-261_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1",
  "productndc": "13107-261",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212429",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "002",
        "approval_date": "Jan 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYCODONE HYDROCHLORIDE",
  "shortage_reason": "Oxycodone Hydrochloride Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "Oxycodone Hydrochloride Oral Solution",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA212429",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone Hydrochloride Oral Solution",
  "start_marketing_date": "20200127",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N02AA05.

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