Montelukast Sodium
- Product NDC
- 63187-896
- 11-digit product format
- 631870896
- Labeler code
- 63187
- Product ID
- 63187-896_c1e8f3ed-105b-4abd-a99e-6a8ebfd6edaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA200405
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Substance
- MONTELUKAST SODIUM
- 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 SODIUM | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 242438 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-896-30 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 3 |
| 63187-896-60 | Montelukast Sodium | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | | 3 |
| 63187-896-90 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-896 | MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191108_0f2dbf17-bce0-4e09-8c22-898d93be80da.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 |
|---|
| 63187-896-30 | 63187089630 | 30 TABLET, CHEWABLE in 1 BOTTLE (63187-896-30) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-896-60 | 63187089660 | 60 TABLET, CHEWABLE in 1 BOTTLE (63187-896-60) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-896-90 | 63187089690 | 90 TABLET, CHEWABLE in 1 BOTTLE (63187-896-90) | 2017-08-01 | 0000-00-00 | No | No | Current |