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United States· US:0904-7095_92f33065-bd48-442a-942c-088d790b955d

OXYCODONE AND ACETAMINOPHEN

A anilides product containing oxycodone and acetaminophen, registered in United States by Major Pharmaceuticals.

In shortageATC N02BEOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedOXYCODONE AND ACETAMINOPHENATCN02BEREGISTER NO.US:0904-7095_92f33065…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
oxycodone and acetaminophen
Manufacturer
Major Pharmaceuticals
Country
United States (US)
ATC code
N02BE
ATC class
Anilides
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0904709561
    100 BLISTER PACK in 1 CARTON (0904-7095-61) / 1 TABLET in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207510
AAAAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/e736cf9f-5c7a-4785-b7e4-950e5946ac91
GET /v1/drugs/e736cf9f-5c7a-4785-b7e4-950e5946ac91?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "0904-7095_92f33065-bd48-442a-942c-088d790b955d",
  "productndc": "0904-7095",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207510",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "001",
        "approval_date": "Mar 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "002",
        "approval_date": "Mar 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "003",
        "approval_date": "Mar 21, 2018"
      }
    ],
    "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": "ANDA207510",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxycodone and acetaminophen",
  "start_marketing_date": "20190601",
  "active_numerator_strength": "325; 10"
}

See everything about oxycodone and acetaminophen.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.