RoxyBond

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerProtega Pharmaceuticals Inc

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8114010310
100 TABLET, COATED in 1 BOTTLE (81140-103-10)

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

N209777

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": {
    "72398542-8e0a-47b2-afeb-9ca5a1f15083": {
      "match": "brand_token",
      "title": "ROXYBOND (OXYCODONE HYDROCHLORIDE) TABLET, COATED [PROTEGA PHARMACEUTICALS INC]",
      "spl_version": "11",
      "published_date": "2026-01-14"
    }
  },
  "productid": "81140-103_484b1240-1832-049e-e063-6394a90aaa6a",
  "productndc": "81140-103",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "209777",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 20, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Apr 20, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Apr 20, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Sep 5, 2024"
      }
    ],
    "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": "RoxyBond",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209777",
  "marketing_category": "NDA",
  "nonproprietary_name": "Oxycodone hydrochloride",
  "start_marketing_date": "20170420",
  "active_numerator_strength": "30"
}

Related drugs

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