NDC 16729-119 – Montelukast Sodium
Montelukast Sodium 10 mg/1 · Tablet, Film Coated · Oral
Product NDC16729-119
Product details
- Brand name
- Montelukast Sodium
- Generic name
- Montelukast Sodium
- Labeler
- Accord Healthcare Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA202717
- Marketed since
- April 11, 2013
- Listing expires
- December 31, 2026
- Pharmacologic class
- Leukotriene Receptor Antagonist
Active ingredients
- Montelukast Sodium 10 mg/1
Uses, dosage, side effects and warnings for Montelukast Sodium →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 16729-119-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10) | Jun 11, 2013 |
| 16729-119-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-119-15) | Apr 11, 2013 |
| 16729-119-17 | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17) | Nov 20, 2014 |
Recalls mentioning this NDC
- D-0400-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection.
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