NDC 33342-111 – Montelukast sodium
Montelukast 5 mg/1 · Tablet, Chewable · Oral
Product NDC33342-111
Product details
- Brand name
- Montelukast sodium
- Generic name
- Montelukast sodium
- Labeler
- Macleods Pharmaceuticals Limited
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Marketing category
- ANDA · ANDA203582
- Marketed since
- March 13, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Leukotriene Receptor Antagonist
Active ingredients
- Montelukast 5 mg/1
Uses, dosage, side effects and warnings for Montelukast Sodium →
Package NDC codes (6)
| Package NDC | Description | Since |
|---|---|---|
| 33342-111-07 | 30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07) | Mar 13, 2015 |
| 33342-111-10 | 90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10) | Mar 13, 2015 |
| 33342-111-12 | 100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12) | Mar 13, 2015 |
| 33342-111-15 | 500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15) | Mar 13, 2015 |
| 33342-111-39 | 90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39) | Mar 13, 2015 |
| 33342-111-44 | 1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44) | Sep 25, 2015 |
Recalls mentioning this NDC
- D-0823-2020 Feb 5, 2020 · Class III
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
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