MONTELUKAST
- Product NDC
- 51128-503
- 11-digit product format
- 511280503
- Labeler code
- 51128
- Product ID
- 51128-503_9eeede6e-480e-4b27-e053-2a95a90a34dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Recipharm Pharmaservices Private Limited
- Application
- ANDA203037
- Marketing category
- ANDA
- Marketing start
- 2014-12-01
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51128-503-01 | 51128050301 | 30 TABLET, CHEWABLE in 1 BOTTLE (51128-503-01) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 51128-503-02 | 51128050302 | 90 TABLET, CHEWABLE in 1 BOTTLE (51128-503-02) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 51128-503-03 | 51128050303 | 1000 TABLET, CHEWABLE in 1 BOTTLE (51128-503-03) | 2014-12-01 | 0000-00-00 | No | No | Current |