MONTELUKAST SODIUM
- Product NDC
- 62135-781
- 11-digit product format
- 621350781
- Labeler code
- 62135
- Product ID
- 62135-781_462a5e7c-f204-7e57-e063-6294a90a896e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA200405
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Substance
- MONTELUKAST SODIUM
- Active strength
- 4 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 | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 242438, 311759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-781-30 | MONTELUKAST SODIUM | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-781 | MONTELUKAST SODIUM TABLET, CHEWABLE [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241025_5cb4298c-10b1-4d6f-95ad-4aad72daf249.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-781-30 | 62135078130 | 30 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30) | 2023-10-06 | No | No | Historical |