Nalocet is a brand name of Oxycodone and acetaminophen, a prescription medicine. The FDA NDC Directory lists 1 Nalocet product in 1 strength and form.

Pharmobedient holds the FDA application for Nalocet (ANDA040608, approved December 30, 2005).

Is there a generic or store brand of Nalocet?

Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Nalocet product, 1 of them generic. Ask your pharmacist whether one is right for you.

Nalocet (Oxycodone and acetaminophen): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Nalocet?: Nalocet is a brand name of Oxycodone and acetaminophen, a prescription medicine. The FDA NDC Directory lists 1 Nalocet product in 1 strength and form.
Who makes Nalocet?: Pharmobedient holds the FDA application for Nalocet (ANDA040608, approved December 30, 2005).
Is there a generic or store brand of Nalocet?: Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Nalocet product, 1 of them generic. Ask your pharmacist whether one is right for you.
Has Nalocet been recalled?: No recall linked to Nalocet products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Nalocet is

Each Nalocet product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Oxycodone and acetaminophen · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
acetaminophen 300 mg · oxycodone hydrochloride 2.5 mg tablet (oral)	Nalocet	1 product, 1 company	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Oxycodone and acetaminophen →

FDA approval

ANDA: Abbreviated New Drug Application: how a generic version is approved.

FDA applications of Nalocet products (Drugs@FDA)
Application	Holder	First approved	Products
ANDA040608	Pharmobedient	December 30, 2005	1

Companies that list Nalocet

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nalocet products.

Forte Bio-Pharma LLC1 product

Recalls

No recall linked to Nalocet products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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Nalocet