Montelukast Sodium
- Product NDC
- 67296-1926
- 11-digit product format
- 672961926
- Labeler code
- 67296
- Product ID
- 67296-1926_4727cc05-2fd8-7524-e063-6394a90a398f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Redpharm Drug
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2013-04-11
- 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 |
|---|
| 67296-1926-3 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1926 | MONTELUKAST SODIUM TABLET, FILM COATED [REDPHARM DRUG] | 1 | Current NDC, 1 package rows | 20250309_2fbdf1be-a37f-879b-e063-6394a90aa20d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-1926-3 | 67296192603 | 30 TABLET, FILM COATED in 1 BOTTLE (67296-1926-3) | 2013-06-11 | No | No | Historical |