montelukast sodium
- Product NDC
- 50090-7925
- 11-digit product format
- 500907925
- Labeler code
- 50090
- Product ID
- 50090-7925_c7c3820a-d9b0-49ff-9bde-483937646621
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2015-05-27
- Substance
- MONTELUKAST
- Active strength
- 5 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- montelukast sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MONTELUKAST | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MHM278SD3E |
| Rxcui | 242438 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7925-0 | montelukast sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 1 |
| 50090-7925-1 | montelukast sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | | 1 |
| 50090-7925-2 | montelukast sodium | 1000 in 1 BOTTLE | TABLET, CHEWABLE | 1000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7925-0 | 50090792500 | 30 TABLET, CHEWABLE in 1 BOTTLE (50090-7925-0) | 2026-03-04 | No | No | Historical |
| 50090-7925-1 | 50090792501 | 90 TABLET, CHEWABLE in 1 BOTTLE (50090-7925-1) | 2026-03-04 | No | No | Historical |
| 50090-7925-2 | 50090792502 | 1000 TABLET, CHEWABLE in 1 BOTTLE (50090-7925-2) | 2026-03-04 | No | No | Historical |