MONTELUKAST SODIUM
- Product NDC
- 72189-418
- 11-digit product format
- 721890418
- Labeler code
- 72189
- Product ID
- 72189-418_2c4d0d3f-0096-e010-e063-6294a90a1ae9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2023-02-02
- 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 |
|---|
| 72189-418-30 | MONTELUKAST SODIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 72189-418-90 | MONTELUKAST SODIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-418 | MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT_RX] | 3 | Current NDC, 2 package rows | 20250123_f3bdf2a3-d661-5128-e053-2995a90a4661.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-418-30 | 72189041830 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30) | 2023-02-02 | No | No | Current |
| 72189-418-90 | 72189041890 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90) | 2023-02-02 | No | No | Current |