Montelukast Sodium
- Product NDC
- 65162-772
- 11-digit product format
- 651620772
- Labeler code
- 65162
- Product ID
- 65162-772_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205107
- Marketing category
- ANDA
- Marketing start
- 2020-09-04
- Substance
- MONTELUKAST SODIUM
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U1O3J18SFL |
| Rxcui | 242438, 311759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-772-03 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-772 | MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [AMNEAL PHARMACEUTICALS LLC] | 20 | Current NDC, Legacy NDC, 1 package rows | 20250419_bcd49102-a21c-4628-a322-6cdd934e7f09.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 |
|---|
| 65162-772-03 | 65162077203 | 30 TABLET, CHEWABLE in 1 BOTTLE (65162-772-03) | 2020-09-04 | 0000-00-00 | No | No | Current |