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United States · US · US:76420-136_ca9b9e11-ae8f-f35e-e053-2a95a90a8762

Oxycodone and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7642013630
    30 TABLET in 1 BOTTLE (76420-136-30)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A201278
AAAAAA
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": "76420-136_ca9b9e11-ae8f-f35e-e053-2a95a90a8762",
  "productndc": "76420-136",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Aug 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "002",
        "approval_date": "Aug 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "003",
        "approval_date": "Aug 28, 2014"
      }
    ],
    "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": "ANDA201278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone and Acetaminophen",
  "start_marketing_date": "20140828",
  "active_numerator_strength": "325; 5"
}

Related drugs

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