montelukast sodium
- Product NDC
- 71335-1995
- 11-digit product format
- 713351995
- Labeler code
- 71335
- Product ID
- 71335-1995_b80634d9-520e-4dd5-920a-76445d9e0c87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204290
- Marketing category
- ANDA
- Marketing start
- 2016-01-01
- 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 |
|---|
| 71335-1995-1 | montelukast sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-1995-2 | montelukast sodium | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 102 |
| 71335-1995-3 | montelukast sodium | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 102 |
| 71335-1995-4 | montelukast sodium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
| 71335-1995-5 | montelukast sodium | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 102 |
| 71335-1995-6 | montelukast sodium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-1995-7 | montelukast sodium | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 102 |
| 71335-1995-8 | montelukast sodium | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1995 | MONTELUKAST SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 8 package rows | 20240502_9beb1510-f3af-4269-a9d0-e2bd41ac369b.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 |
|---|
| 71335-1995-1 | 71335199501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1) | 2021-12-16 | 0000-00-00 | No | No | Current |
| 71335-1995-2 | 71335199502 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1995-3 | 71335199503 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1995-4 | 71335199504 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4) | 2022-05-09 | 0000-00-00 | No | No | Current |
| 71335-1995-5 | 71335199505 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1995-6 | 71335199506 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6) | 2021-12-08 | 0000-00-00 | No | No | Current |
| 71335-1995-7 | 71335199507 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1995-8 | 71335199508 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8) | 2024-04-03 | 0000-00-00 | No | No | Current |