Montelukast Sodium
- Product NDC
- 71610-026
- 11-digit product format
- 716100026
- Labeler code
- 71610
- Product ID
- 71610-026_f5d86ed6-c804-4fe8-ac6d-adb40336aab3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202096
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-026 | MONTELUKAST SODIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC | 20190610_3296ee60-c7ab-4ada-aa1a-e498df60be4d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-026-30 | 71610002630 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-026-30) | 2016-10-14 | 0000-00-00 | No | No | Current |
| 71610-026-60 | 71610002660 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-026-60) | 2016-10-14 | 0000-00-00 | No | No | Current |