Drugplain

Hydroxyurea 500 mg/1

Hydroxyurea · CAPSULE · Par Health USA, LLC

3 Recalls on Record
Plain English

Hydroxyurea is an antimetabolite medication taken by mouth that is used to treat certain blood disorders including sickle cell disease and some cancers. Your doctor will determine the appropriate dose for your condition based on your individual needs and blood counts.

Key Facts

Brand Name
Hydroxyurea
Generic Name
Hydroxyurea
NDC Code (Product)
49884-724
Manufacturer
Par Health USA, LLC
Strength
500 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA075340
Drug Class
Antimetabolite [EPC]
Marketing Start
02/24/1999

Recall History

3 Recalls on Record
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated
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 II02/12/2015

Health Innovations Pharmacy, Inc

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use1,670 reports
sickle cell anaemia with crisis1,227 reports
fatigue1,128 reports
diarrhoea1,092 reports
nausea984 reports
headache818 reports
death756 reports
product dose omission issue743 reports
drug ineffective714 reports
haemoglobin decreased673 reports

Frequently Asked Questions

What is Hydroxyurea used for?

Hydroxyurea is an antimetabolite medication taken by mouth that is used to treat certain blood disorders including sickle cell disease and some cancers. Your doctor will determine the appropriate dose for your condition based on your individual needs and blood counts.

Is Hydroxyurea a controlled substance?

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

What is the generic name for Hydroxyurea?

The generic name for Hydroxyurea is Hydroxyurea. There are 10 other brand versions of Hydroxyurea.

What is the NDC code for Hydroxyurea 500 mg/1?

The NDC (National Drug Code) for Hydroxyurea 500 mg/1 is 49884-724, listed by Par Health USA, LLC.

Product NDC

49884-724

Package NDC

49884-724-01

Other Hydroxyurea Dosages

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

Data from openFDA · Public domain (CC0 1.0)