Montelukast Sodium
- Product NDC
- 59651-329
- 11-digit product format
- 596510329
- Labeler code
- 59651
- Product ID
- 59651-329_2fcb1880-c88e-4c82-829e-6177a07814c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213471
- Marketing category
- ANDA
- Marketing start
- 2020-02-18
- 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 | 351246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-329-05 | Montelukast Sodium | 1 in 1 PACKET | GRANULE | 1 | | 8 |
| 59651-329-30 | Montelukast Sodium | 30 in 1 CARTON | GRANULE | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-329 | MONTELUKAST SODIUM GRANULE [AUROBINDO PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230604_9a3bfc59-0ca6-4433-abf5-41659bfe0a8f.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 |
|---|
| 59651-329-05 | 59651032905 | 1 in 1 PACKET | | | | | | Historical |
| 59651-329-30 | 59651032930 | 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05) | 30 packet | 2020-02-18 | 0000-00-00 | No | No | Current |