Montelukast Sodium
- Product NDC
- 63629-4978
- 11-digit product format
- 636294978
- Labeler code
- 63629
- Product ID
- 63629-4978_6e0393b3-38c8-49e6-a0ff-875499974a51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202096
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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
- 2023-12-31
- 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 |
|---|
| 63629-4978-1 | 63629497801 | 30 TABLET, CHEWABLE in 1 BOTTLE (63629-4978-1) | 2013-04-12 | 0000-00-00 | No | No | Current |
| 63629-4978-2 | 63629497802 | 90 TABLET, CHEWABLE in 1 BOTTLE (63629-4978-2) | 2014-06-06 | 0000-00-00 | No | No | Current |
| 63629-4978-3 | 63629497803 | 60 TABLET, CHEWABLE in 1 BOTTLE (63629-4978-3) | 2022-02-08 | 0000-00-00 | No | No | Current |
| 63629-4978-4 | 63629497804 | 28 TABLET, CHEWABLE in 1 BOTTLE (63629-4978-4) | 2022-02-08 | 0000-00-00 | No | No | Current |