Montelukast Sodium
- Product NDC
- 63187-430
- 11-digit product format
- 631870430
- Labeler code
- 63187
- Product ID
- 63187-430_3987b125-2cd5-4cae-9009-4e839599a38e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201515
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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 |
|---|
| 63187-430-30 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 63187-430-60 | Montelukast Sodium | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 63187-430-90 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-430 | MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20191121_8a724790-e1fb-4935-bb28-ce99455be5ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-430-30 | 63187043030 | 30 TABLET in 1 BOTTLE (63187-430-30) | 30 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 63187-430-60 | 63187043060 | 60 TABLET in 1 BOTTLE (63187-430-60) | 60 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |
| 63187-430-90 | 63187043090 | 90 TABLET in 1 BOTTLE (63187-430-90) | 90 tablet | 2014-03-03 | 0000-00-00 | No | No | Current |