OXYCODONE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0121082704
118 mL in 1 BOTTLE (0121-0827-04)
ndc11
0121082716
500 mL in 1 BOTTLE (0121-0827-16)

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

A206914

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": "0121-0827_1685138a-dd0b-4e6e-b14d-a1132eef8b34",
  "productndc": "0121-0827",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206914",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 1, 2019"
      }
    ],
    "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",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA206914",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXYCODONE HYDROCHLORIDE",
  "start_marketing_date": "20190408",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N02AA05.

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