Montelukast Sodium
- Product NDC
- 13668-081
- 11-digit product format
- 136680081
- Labeler code
- 13668
- Product ID
- 13668-081_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 200224, 242438, 311759, 351246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-081-05 | Montelukast Sodium | 500 in 1 BOTTLE | TABLET | 500 | | 23 |
| 13668-081-30 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 23 |
| 13668-081-32 | Montelukast Sodium | 3200 in 1 BOTTLE | TABLET | 3200 | | 23 |
| 13668-081-74 | Montelukast Sodium | 100 in 1 CARTON | TABLET | 100 | | 23 |
| 13668-081-90 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-081 | MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED] | 22 | Current NDC, Legacy NDC, 5 package rows | 20250529_da038cf6-cfad-43a4-ab8e-d81d028d6087.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 |
|---|
| 13668-081-05 | 13668008105 | 500 TABLET in 1 BOTTLE (13668-081-05) | 500 tablet | 2012-08-03 | 0000-00-00 | No | No | Current |
| 13668-081-30 | 13668008130 | 30 TABLET in 1 BOTTLE (13668-081-30) | 30 tablet | 2012-08-03 | 0000-00-00 | No | No | Current |
| 13668-081-32 | 13668008132 | 3200 TABLET in 1 BOTTLE (13668-081-32) | 3200 tablet | 2012-08-03 | 0000-00-00 | No | No | Current |
| 13668-081-74 | 13668008174 | 100 TABLET in 1 CARTON (13668-081-74) | 100 tablet | 2012-08-03 | 0000-00-00 | No | No | Current |
| 13668-081-90 | 13668008190 | 90 TABLET in 1 BOTTLE (13668-081-90) | 90 tablet | 2012-08-03 | 0000-00-00 | No | No | Current |