Montelukast
- Product NDC
- 71335-1979
- 11-digit product format
- 713351979
- Labeler code
- 71335
- Product ID
- 71335-1979_cf8b88f1-1781-4f41-ae5d-15641554fa75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2014-09-10
- 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
- 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 |
|---|
| 71335-1979-1 | Montelukast | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 104 |
| 71335-1979-2 | Montelukast | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 104 |
| 71335-1979-3 | Montelukast | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 104 |
| 71335-1979-4 | Montelukast | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 104 |
| 71335-1979-5 | Montelukast | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 104 |
| 71335-1979-6 | Montelukast | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 104 |
| 71335-1979-7 | Montelukast | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 104 |
| 71335-1979-8 | Montelukast | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1979 | MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 8 package rows | 20240809_6b26218d-52a6-4109-90e4-412a17d14fcf.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 |
|---|
| 71335-1979-1 | 71335197901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1979-1) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-2 | 71335197902 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-1979-2) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-3 | 71335197903 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1979-3) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-4 | 71335197904 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1979-4) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-5 | 71335197905 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1979-5) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-6 | 71335197906 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1979-6) | 2021-10-27 | 0000-00-00 | No | No | Current |
| 71335-1979-7 | 71335197907 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1979-7) | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1979-8 | 71335197908 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1979-8) | 2021-12-21 | 0000-00-00 | No | No | Current |