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United States · US · US:50268-644_48ec761b-a7bc-59ef-e063-6294a90a579b

Oxycodone and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026864415
    50 BLISTER PACK in 1 BOX (50268-644-15) / 1 TABLET in 1 BLISTER PACK (50268-644-11)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040777
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "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": "50268-644_48ec761b-a7bc-59ef-e063-6294a90a579b",
  "productndc": "50268-644",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040777",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Oxycodone and Acetaminophen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040777",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone and Acetaminophen",
  "start_marketing_date": "20180709",
  "active_numerator_strength": "325; 5"
}

Related drugs

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