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United States · US · US:42806-061_8cd322df-f304-482e-9ed5-a7afa26f5645

Oxycodone and Aspirin

Orange BookUNIISPLATC A01AD

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

Identification

ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4280606101
    100 TABLET in 1 BOTTLE (42806-061-01)

Annotations

UNII (FDA Substance ID)
R16CO5Y76E
ASPIRIN
RxCUI 1191
Orange Book
A040910
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R16CO5Y76E",
    "rxcui": "1191",
    "inchikey": "BSYNRYMUTXBXSQ-UHFFFAOYSA-N",
    "display_name": "ASPIRIN",
    "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": "42806-061_8cd322df-f304-482e-9ed5-a7afa26f5645",
  "productndc": "42806-061",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040910",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "325MG;4.8355MG",
        "product_no": "001",
        "approval_date": "Jul 16, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASPIRIN; OXYCODONE HYDROCHLORIDE",
  "proprietary_name": "Oxycodone and Aspirin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040910",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone and Aspirin",
  "start_marketing_date": "20200630",
  "active_numerator_strength": "325; 4.8355"
}

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