MONTELUKAST SODIUM
- Product NDC
- 72189-223
- 11-digit product format
- 721890223
- Labeler code
- 72189
- Product ID
- 72189-223_2c283d75-2454-ee48-e063-6294a90a7651
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- Substance
- MONTELUKAST
- Active strength
- 5 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 | 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 |
|---|
| 72189-223-30 | MONTELUKAST SODIUM | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-223 | MONTELUKAST SODIUM TABLET, CHEWABLE [DIRECT RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250121_c2d834e6-7b38-d266-e053-2995a90a27ef.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 |
|---|
| 72189-223-30 | 72189022330 | 30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30) | 2021-05-21 | 0000-00-00 | No | No | Current |