Montelukast Sodium
- Product NDC
- 55154-8075
- 11-digit product format
- 551548075
- Labeler code
- 55154
- Product ID
- 55154-8075_2106fae5-cfb5-49f9-bf0b-72e7dcb18b8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2014-09-10
- 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 |
|---|
| 55154-8075-0 | Montelukast Sodium | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 55154-8075-0 | Montelukast Sodium | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8075 | MONTELUKAST TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250312_9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-8075-0 | 55154807500 | 10 BLISTER PACK in 1 BAG (55154-8075-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2014-09-10 | 0000-00-00 | No | No | Current |