Montelukast Sodium
- Product NDC
- 53002-4730
- 11-digit product format
- 530024730
- Labeler code
- 53002
- Product ID
- 53002-4730_2817bd5b-7849-4756-9de5-04ba813ab056
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4730-1 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4730 | MONTELUKAST SODIUM TABLET, CHEWABLE [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_cf92d18d-02a9-4710-8b6c-65ac48dacf34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-4730-1 | 53002473001 | 30 TABLET, CHEWABLE in 1 BOTTLE (53002-4730-1) | 2022-02-01 | 0000-00-00 | No | No | Current |