Montelukast Sodium
- Product NDC
- 43063-762
- 11-digit product format
- 430630762
- Labeler code
- 43063
- Product ID
- 43063-762_414b7ce2-7550-5e40-e063-6294a90afda2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 |
|---|
| 43063-762-30 | Montelukast Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-762 | MONTELUKAST SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 1 package rows | 20241016_c9ec1996-6a54-4622-b8a6-57dea49f6b35.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 |
|---|
| 43063-762-30 | 43063076230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-762-30) | 2017-05-04 | 0000-00-00 | No | No | Current |