MONTELUKAST SODIUM
- Product NDC
- 16571-100
- 11-digit product format
- 165710100
- Labeler code
- 16571
- Product ID
- 16571-100_c3c93ca9-9367-4426-b310-5507dd588b08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA209012
- Marketing category
- ANDA
- Marketing start
- 2023-06-01
- 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 |
|---|
| 16571-100-09 | MONTELUKAST SODIUM | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 16571-100-10 | MONTELUKAST SODIUM | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-100 | MONTELUKAST SODIUM TABLET [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 2 package rows | 20240822_75723c5a-3c9e-468a-bc65-57b4c755889a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-100-09 | 16571010009 | 90 TABLET in 1 BOTTLE (16571-100-09) | 90 tablet | 2023-06-01 | No | No | Current |
| 16571-100-10 | 16571010010 | 1000 TABLET in 1 BOTTLE (16571-100-10) | 1000 tablet | 2023-06-01 | No | No | Current |