OXYCODONE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerSpecGx LLC

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0406055201
100 TABLET in 1 BOTTLE (0406-0552-01)
ndc11
0406055223
1 TABLET in 1 BLISTER PACK (0406-0552-23)
ndc11
0406055262
100 TABLET in 1 BLISTER PACK (0406-0552-62)

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

A076758

ABABABABAB

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": "0406-0552_d2534006-67e9-4e2a-a4f8-1e44d5857af5",
  "productndc": "0406-0552",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076758",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jun 30, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 30, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Mar 19, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Oct 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Oct 12, 2021"
      }
    ],
    "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/1",
  "application_number": "ANDA076758",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxycodone hydrochloride",
  "start_marketing_date": "20040630",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N02AA05.

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