Montelukast 10 mg/1
Montelukast · TABLET, FILM COATED · Aphena Pharma Solutions - Tennessee, LLC
Montelukast is a prescription tablet used to treat asthma and allergic rhinitis by reducing inflammation and constriction in the airways. It is taken by mouth and belongs to a class of medications called leukotriene receptor antagonists.
Key Facts
- Brand Name
- Montelukast
- Generic Name
- Montelukast
- NDC Code (Product)
71610-563- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202843
- Marketing Start
- 02/11/2021
Recall History
Teva Pharmaceuticals USA Inc
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
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.
Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
PD-Rx Pharmaceuticals, Inc.
CGMP deviations.
Hetero Labs Limited Unit V
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Macleods Pharma Usa Inc
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Direct Rx
cGMP deviations
Hetero Labs Limited Unit V
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is Montelukast used for?
Montelukast is a prescription tablet used to treat asthma and allergic rhinitis by reducing inflammation and constriction in the airways. It is taken by mouth and belongs to a class of medications called leukotriene receptor antagonists.
Is Montelukast a controlled substance?
Montelukast is not classified as a controlled substance by the DEA.
What is the generic name for Montelukast?
The generic name for Montelukast is Montelukast. There are 7 other brand versions of Montelukast.
What is the NDC code for Montelukast 10 mg/1?
The NDC (National Drug Code) for Montelukast 10 mg/1 is 71610-563, listed by Aphena Pharma Solutions - Tennessee, LLC.