Montelukast Sodium
- Product NDC
- 43063-381
- 11-digit product format
- 430630381
- Labeler code
- 43063
- Product ID
- 43063-381_509acd9d-2a2a-42e5-e063-6294a90a5b42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090984
- 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
- 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 SODIUM | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 311759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-381-21 | Montelukast Sodium | 21 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 21 | | 27 |
| 43063-381-30 | Montelukast Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 30 | | 27 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-381 | MONTELUKAST SODIUM TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 2 package rows | 20250110_c69ab399-8ea6-4002-9271-b6a57c862b14.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 |
|---|
| 43063-381-21 | 43063038121 | 21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21) | 2015-11-05 | 0000-00-00 | No | No | Current |
| 43063-381-30 | 43063038130 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30) | 2015-11-05 | 0000-00-00 | No | No | Current |