Oxycodone Hydrochloride

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerGenus Lifesciences Inc.

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6495035410
1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC
ndc11
6495035445
40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)
ndc11
6495035450
1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC
ndc11
6495035455
50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)

Annotations

UNII (FDA Substance ID)

C1ENJ2TE6C

OXYCODONE HYDROCHLORIDE

RxCUI 82063

Orange Book

N200535

AAAA

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": "64950-354_75ee6920-096a-4dd9-ae98-6991ab84daff",
  "productndc": "64950-354",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "200535",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 20, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Aug 22, 2013"
      }
    ],
    "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": "Oxycodone Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA200535",
  "marketing_category": "NDA",
  "nonproprietary_name": "Oxycodone Hydrochloride",
  "start_marketing_date": "20130909",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N02AA05.

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