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United States · US · US:23635-582_9c646c9c-3074-4250-8191-82ac61b515a4

Roxicodone

In shortageOrange BookUNIISPLATC N02AA05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2363558210
    100 TABLET in 1 BOTTLE, PLASTIC (23635-582-10)

Annotations

UNII (FDA Substance ID)
C1ENJ2TE6C
OXYCODONE HYDROCHLORIDE
RxCUI 82063
Orange Book
N021011
ABABAB
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": {
    "5a8157d3-ba20-4abf-b0d4-6ad141b31d63": {
      "match": "brand_token",
      "title": "ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [SPECGX LLC]",
      "spl_version": "30",
      "published_date": "2026-04-30"
    }
  },
  "productid": "23635-582_9c646c9c-3074-4250-8191-82ac61b515a4",
  "productndc": "23635-582",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021011",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Aug 31, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "May 15, 2009"
      }
    ],
    "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": "Roxicodone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021011",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxycodone hydrochloride",
  "start_marketing_date": "20000831",
  "active_numerator_strength": "30"
}

Related drugs

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