Montelukast Sodium
- Product NDC
- 69367-287
- 11-digit product format
- 693670287
- Labeler code
- 69367
- Product ID
- 69367-287_1026f850-9f36-346f-e063-6394a90a2373
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA205683
- Marketing category
- ANDA
- Marketing start
- 2016-05-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Montelukast Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MONTELUKAST SODIUM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 200224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-287-05 | Montelukast Sodium | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
| 69367-287-09 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-287 | MONTELUKAST SODIUM TABLET [WESTMINSTER PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240131_c0daaaf3-6717-4a01-e053-2995a90af2d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69367-287-05 | 69367028705 | 500 TABLET in 1 BOTTLE (69367-287-05) | 500 tablet | 2021-04-25 | 0000-00-00 | No | No | Current |
| 69367-287-09 | 69367028709 | 90 TABLET in 1 BOTTLE (69367-287-09) | 90 tablet | 2021-04-25 | 0000-00-00 | No | No | Current |