Drugplain

Ketoprofen 50 mg/1

Ketoprofen · CAPSULE · Oncora Pharma, LLC

5 Recalls on Record
Plain English

Ketoprofen is a capsule containing ketoprofen at 50 mg/1, taken oral. Manufactured by Oncora Pharma, LLC.

Key Facts

Brand Name
Ketoprofen
Generic Name
Ketoprofen
NDC Code (Product)
85477-111
Manufacturer
Oncora Pharma, LLC
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA074014
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
03/01/2026

Recall History

5 Recalls on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated
Class II04/06/2020

The Medicine Shoppe Pharmacy

Lack of Processing Control

TerminatedVoluntary: Firm initiated
Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated
Class II05/29/2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache1,162 reports
pain1,085 reports
fatigue877 reports
drug ineffective748 reports
nausea748 reports
off label use721 reports
pyrexia721 reports
infusion site pain718 reports
rheumatoid arthritis683 reports
hypersensitivity679 reports

Frequently Asked Questions

What is Ketoprofen used for?

Ketoprofen contains Ketoprofen. It is a capsule taken oral. Consult your doctor for specific uses.

Is Ketoprofen a controlled substance?

Ketoprofen is not classified as a controlled substance by the DEA.

What is the generic name for Ketoprofen?

The generic name for Ketoprofen is Ketoprofen. There are 1 other brand versions of Ketoprofen.

What is the NDC code for Ketoprofen 50 mg/1?

The NDC (National Drug Code) for Ketoprofen 50 mg/1 is 85477-111, listed by Oncora Pharma, LLC.

Product NDC

85477-111

Package NDC

85477-111-01

Other Ketoprofen Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)