OxyContin

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerKnoa Pharma LLC

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5901141510
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59011-415-10)
ndc11
5901141520
2 BLISTER PACK in 1 CARTON (59011-415-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

N022272

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": {
    "bfdfe235-d717-4855-a3c8-a13d26dadede": {
      "match": "brand_token",
      "title": "OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KNOA PHARMA LLC]",
      "spl_version": "43",
      "published_date": "2026-05-13"
    }
  },
  "productid": "59011-415_4a1edd18-f1f0-4609-9eaf-29067937c3c6",
  "productndc": "59011-415",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022272",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "005",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Apr 5, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "007",
        "approval_date": "Apr 5, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYCODONE HYDROCHLORIDE",
  "shortage_reason": "Oxycodone Hydrochloride Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "OxyContin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022272",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxycodone hydrochloride",
  "start_marketing_date": "20100808",
  "active_numerator_strength": "15"
}

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