montelukast sodium
- Product NDC
- 71335-1602
- 11-digit product format
- 713351602
- Labeler code
- 71335
- Product ID
- 71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2015-05-27
- 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 | 311759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1602-1 | montelukast sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 5 |
| 71335-1602-2 | montelukast sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | | 5 |
| 71335-1602-3 | montelukast sodium | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1602 | MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241022_3ff4100f-11e3-4d6a-ab88-83bd605a1818.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 |
|---|
| 71335-1602-1 | 71335160201 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1) | 2020-05-13 | 0000-00-00 | No | No | Current |
| 71335-1602-2 | 71335160202 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2) | 2020-05-13 | 0000-00-00 | No | No | Current |
| 71335-1602-3 | 71335160203 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3) | 2022-02-14 | 0000-00-00 | No | No | Current |