MONTELUKAST SODIUM
- Product NDC
- 53217-357
- 11-digit product format
- 532170357
- Labeler code
- 53217
- Product ID
- 53217-357_a58c1900-948f-4535-9811-78e075005a16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA203328
- Marketing category
- ANDA
- Marketing start
- 2017-12-26
- 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
- 2019-12-31
- 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 |
|---|
| 53217-357-30 | 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 |
|---|
| 53217-357 | MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180820_147725da-4c8b-4608-87a9-053311d0aba0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-357-30 | 53217035730 | 30 in 1 BOTTLE | Historical |