Montelukast Sodium
- Product NDC
- 71335-0514
- 11-digit product format
- 713350514
- Labeler code
- 71335
- Product ID
- 71335-0514_dd8189d6-e479-4e78-812c-523db9c3bdae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2013-04-11
- 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 |
|---|
| 71335-0514-1 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 71335-0514-2 | Montelukast Sodium | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 8 |
| 71335-0514-3 | Montelukast Sodium | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 8 |
| 71335-0514-4 | Montelukast Sodium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
| 71335-0514-5 | Montelukast Sodium | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 8 |
| 71335-0514-6 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
| 71335-0514-7 | Montelukast Sodium | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 8 |
| 71335-0514-8 | Montelukast Sodium | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0514 | MONTELUKAST SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] | 8 | Current NDC, Legacy NDC, 8 package rows | 20231102_4ba27278-6249-4546-9331-b19302cbf2db.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 |
|---|
| 71335-0514-1 | 71335051401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0514-1) | 2018-03-08 | 0000-00-00 | No | No | Current |
| 71335-0514-2 | 71335051402 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-0514-2) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0514-3 | 71335051403 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-0514-3) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0514-4 | 71335051404 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0514-4) | 2018-08-29 | 0000-00-00 | No | No | Current |
| 71335-0514-5 | 71335051405 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-0514-5) | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0514-6 | 71335051406 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0514-6) | 2018-02-12 | 0000-00-00 | No | No | Current |
| 71335-0514-7 | 71335051407 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0514-7) | 2019-04-12 | 0000-00-00 | No | No | Current |
| 71335-0514-8 | 71335051408 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0514-8) | 2021-12-27 | 0000-00-00 | No | No | Current |