Montelukast Sodium
- Product NDC
- 62175-204
- 11-digit product format
- 621750204
- Labeler code
- 62175
- Product ID
- 62175-204_a4215d29-ef78-4b4d-9683-9dc4d35e345a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA200405
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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 |
|---|---|
| MONTELUKAST SODIUM | 4 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U1O3J18SFL |
| Rxcui | 242438, 311759 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 8d8a355b-240d-8c38-7331-c9e3c1068a33 | Product name | 9 | 20161220 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62175-204-32 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 37 | |
| 62175-204-43 | Montelukast Sodium | 1000 in 1 BOTTLE | TABLET, CHEWABLE | 1000 | 37 | |
| 62175-204-46 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | 37 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62175-204-32 | EA - Each | 62175-204 | 88c48138-6122-48a7-a171-5d1afab280ad | 1 | 2013-02-13 |
| 62175-204-43 | EA - Each | 62175-204 | 4c962020-05f0-488d-9c20-d056ae67eed0 | 1 | 2013-02-13 |
| 62175-204-46 | EA - Each | 62175-204 | bcbefa5e-b428-46ca-b337-d5d4e1c43982 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311759 | montelukast sodium 4 MG Chewable Tablet | PSN | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 242438 | montelukast sodium 5 MG Chewable Tablet | PSN | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 311759 | montelukast 4 MG Chewable Tablet | SCD | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 242438 | montelukast 5 MG Chewable Tablet | SCD | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 311759 | montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet | SY | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 242438 | montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet | SY | c43d1edb-c162-4317-9a89-d84e4eff5512 | 37 |
| 200224 | montelukast sodium 10 MG Oral Tablet | PSN | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 311759 | montelukast sodium 4 MG Chewable Tablet | PSN | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 242438 | montelukast sodium 5 MG Chewable Tablet | PSN | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 200224 | montelukast 10 MG Oral Tablet | SCD | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 311759 | montelukast 4 MG Chewable Tablet | SCD | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 242438 | montelukast 5 MG Chewable Tablet | SCD | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 200224 | montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet | SY | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 311759 | montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet | SY | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 242438 | montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet | SY | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 22 |
| 200224 | montelukast sodium 10 MG Oral Tablet | PSN | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 311759 | montelukast sodium 4 MG Chewable Tablet | PSN | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 242438 | montelukast sodium 5 MG Chewable Tablet | PSN | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 200224 | montelukast 10 MG Oral Tablet | SCD | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 311759 | montelukast 4 MG Chewable Tablet | SCD | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 242438 | montelukast 5 MG Chewable Tablet | SCD | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 200224 | montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet | SY | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 311759 | montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet | SY | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 242438 | montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet | SY | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 8 |
| 311759 | montelukast sodium 4 MG Chewable Tablet | PSN | 83c35a3d-0bbc-4598-bf76-ab0c2903bf19 | 2 |
| 311759 | montelukast 4 MG Chewable Tablet | SCD | 83c35a3d-0bbc-4598-bf76-ab0c2903bf19 | 2 |
| 311759 | montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet | SY | 83c35a3d-0bbc-4598-bf76-ab0c2903bf19 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62175-204-32 | 62175020432 | 30 TABLET, CHEWABLE in 1 BOTTLE (62175-204-32) | 2012-08-03 | 0000-00-00 | No | No | Current |
| 62175-204-43 | 62175020443 | 1000 TABLET, CHEWABLE in 1 BOTTLE (62175-204-43) | 2012-08-03 | 0000-00-00 | No | No | Current |
| 62175-204-46 | 62175020446 | 90 TABLET, CHEWABLE in 1 BOTTLE (62175-204-46) | 2012-08-03 | 0000-00-00 | No | No | Current |