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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U1O3J18SFL | MONTELUKAST SODIUM | 151767-02-1 | MONTELUKAST SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1995-1 | 71335199501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1) | 2021-12-16 | No | No | Historical |
| 71335-1995-2 | 71335199502 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2) | 2024-04-03 | No | No | Historical |
| 71335-1995-3 | 71335199503 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3) | 2024-04-03 | No | No | Historical |
| 71335-1995-4 | 71335199504 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4) | 2022-05-09 | No | No | Historical |
| 71335-1995-5 | 71335199505 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5) | 2024-04-03 | No | No | Historical |
| 71335-1995-6 | 71335199506 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6) | 2021-12-08 | No | No | Historical |
| 71335-1995-7 | 71335199507 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7) | 2024-04-03 | No | No | Historical |
| 71335-1995-8 | 71335199508 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8) | 2024-04-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| montelukast sodium | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 102 |