Ondansetron HCL 8 mg/1
Ondansetron HCL · TABLET, FILM COATED · Advanced Rx of Tennessee, LLC
Ondansetron HCL is a tablet, film coated containing ondansetron hcl at 8 mg/1, taken oral. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- Ondansetron HCL
- Generic Name
- Ondansetron HCL
- NDC Code (Product)
80425-0074- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 8 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078539
- Marketing Start
- 09/16/2020
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Frequently Asked Questions
What is Ondansetron HCL used for?
Ondansetron HCL contains Ondansetron HCL. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Ondansetron HCL a controlled substance?
Ondansetron HCL is not classified as a controlled substance by the DEA.
What is the generic name for Ondansetron HCL?
The generic name for Ondansetron HCL is Ondansetron HCL. There are no other listed brand versions of Ondansetron HCL.
What is the NDC code for Ondansetron HCL 8 mg/1?
The NDC (National Drug Code) for Ondansetron HCL 8 mg/1 is 80425-0074, listed by Advanced Rx of Tennessee, LLC.
Other Ondansetron HCL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)