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Brand-name prescription medicine

Norco

Generic name: Hydrocodone bitartrate and acetaminophen

FDA application holder: Specgx LLC

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 Norco?
Norco is a brand name of Hydrocodone bitartrate and acetaminophen, a prescription medicine. The FDA NDC Directory lists 1 Norco product in 1 strength and form.
Who makes Norco?
Specgx LLC holds the FDA application for Norco (ANDA040400, approved July 26, 2000).
Is there a generic or store brand of Norco?
Yes. The FDA NDC Directory lists 51 other products with the same active ingredients, strength and form as a Norco product, 51 of them generic. Ask your pharmacist whether one is right for you.
Has Norco been recalled?
No recall linked to Norco products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Norco is

Each Norco 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.

Hydrocodone bitartrate and acetaminophen · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
acetaminophen 325 mg · hydrocodone bitartrate 10 mg
tablet (oral)
Norco 51 products, 25 companies DailyMed

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

FDA approval

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
FDA applications of Norco products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA040400Specgx LLCJuly 26, 20001

Companies that list Norco

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

Recalls

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

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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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