Montelukast
- Product NDC
- 82009-009
- 11-digit product format
- 820090009
- Labeler code
- 82009
- Product ID
- 82009-009_2f3344ca-4170-1e1b-e063-6394a90a426b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2022-06-07
- 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 |
|---|
| 82009-009-10 | Montelukast | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-009 | MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250302_5d71088b-b0fa-4bf0-a6e7-6163bd9e0dd4.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 |
|---|
| 82009-009-10 | 82009000910 | 1000 TABLET, FILM COATED in 1 BOTTLE (82009-009-10) | 2022-06-07 | 0000-00-00 | No | No | Current |