United States· US:72245-193_502384f0-4ffd-5d16-e063-6394a90ad304

Nalocet

A anilides product containing oxycodone and acetaminophen, registered in United States by Forte Bio-Pharma LLC.

In shortageATC N02BEOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about oxycodone and acetaminophenAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: oxycodone and acetaminophen
Manufacturer: Forte Bio-Pharma LLC
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 · 2

ndc11
7224519303
30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03)
ndc11
7224519310
100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10)

Regulatory notes

UNII (FDA substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A040608

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Acetaminophen; Oxycodone Hydrochloride Tablet

Same class

Other records under N02BE

Anilides, as other registers publish it.

All oxycodone and acetaminophen products

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/27fa5d7d-06f5-41b6-b52e-36ed5a1b8ba8
GET /v1/drugs/27fa5d7d-06f5-41b6-b52e-36ed5a1b8ba8?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": {
    "f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be": {
      "match": "brand_token",
      "title": "NALOCET (OXYCODONE AND ACETAMINOPHEN) TABLET [FORTE BIO-PHARMA LLC]",
      "spl_version": "8",
      "published_date": "2026-04-27"
    }
  },
  "productid": "72245-193_502384f0-4ffd-5d16-e063-6394a90ad304",
  "productndc": "72245-193",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040608",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;2.5MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;5MG",
        "product_no": "002",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;7.5MG",
        "product_no": "003",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;10MG",
        "product_no": "004",
        "approval_date": "Dec 30, 2005"
      }
    ],
    "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": "Nalocet",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040608",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxycodone and acetaminophen",
  "start_marketing_date": "20180523",
  "active_numerator_strength": "300; 2.5"
}

API reference MCP server Plans

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.

Try it free Open in the console