NDC 50268-556
Montelukast 10 mg tablet, film coated
On the label: AvPAK. It's repackaged: AvPAK rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-726.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Camber Pharmaceuticals Inc. names for other drugs.
Recalls
- Aug 20, 2018 · Class II · Hetero Labs Limited Unit V
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Lots: Lot #: MON17355, Exp 12/19 - Aug 15, 2018 · Class I · 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.
Lots: Lot #: MON17384, Exp 12/19 - Jan 7, 2017 · Class III · Hetero USA Inc
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Lots: Lot # MON16001B, Exp 01/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA202843
- On the market since
- Feb 8, 2022
- Package NDCs
50268-556-1150268-556-15- Official label
- DailyMed (National Library of Medicine), updated Jan 8, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?