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Brand-name prescription medicine

Ibu

Generic name: Ibuprofen

FDA application holder: Dr Reddys

Strengths and generic versions Official label

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.

At a glance

3Strengths and forms
99Same medicine, other names
2001FDA approval
5Recalls (FDA reports)

Quick answers

What is Ibu?
Ibu is a brand name of Ibuprofen, a prescription medicine. The FDA NDC Directory lists 14 Ibu products in 3 strengths and forms.
Who makes Ibu?
Dr Reddys holds the FDA application for Ibu (ANDA075682, approved November 14, 2001). 5 other companies (repackagers or distributors) also list Ibu products.
Is there a generic or store brand of Ibu?
Yes. The FDA NDC Directory lists 99 other products with the same active ingredients, strength and form as a Ibu product, 99 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Ibu?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 3 Ibu strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Ibu been recalled?
FDA enforcement reports list 5 recalls of Ibu products; the newest started October 29, 2024. A recall usually concerns specific lots, not every product.

What Ibu is

Each Ibu 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.

Ibuprofen · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
ibuprofen 400 mg
tablet (oral)		 Ibu 26 products, 21 companies DailyMed
ibuprofen 600 mg
tablet (oral)		 Ibu 29 products, 21 companies DailyMed
ibuprofen 800 mg
tablet (oral)		 Ibu 44 products, 27 companies DailyMed

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

FDA approval

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
FDA applications of Ibu products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA075682Dr ReddysNovember 14, 200114

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ibu, by strength and form
Strength and formGeneric or brandPharmacies pay
ibuprofen 400 mg
tablet		 Generic: Ibu $0.0375 per tablet
Generic of the same strength and form: $0.0375 per tablet
ibuprofen 600 mg
tablet		 Generic: Ibu $0.0461 per tablet
Generic of the same strength and form: $0.0461 per tablet
ibuprofen 800 mg
tablet		 Generic: Ibu $0.0555 per tablet
Generic of the same strength and form: $0.0555 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Ibu

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

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. October 29, 2024 · Class III · Ongoing · D-0047-2025

    Failed Tablet/Capsule Specifications

    IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 — Dr. Reddy's Laboratories, Inc.

  2. August 6, 2024 · Class II · Ongoing · D-0646-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  3. August 6, 2024 · Class II · Ongoing · D-0644-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  4. August 6, 2024 · Class II · Ongoing · D-0645-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  5. August 29, 2013 · Class II · Terminated · D-1042-2013

    Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

    IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA. — Dr. Reddy's Laboratories, Inc.

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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