montelukast sodium
- Product NDC
- 68071-2846
- 11-digit product format
- 680712846
- Labeler code
- 68071
- Product ID
- 68071-2846_ea764c40-6648-3f9f-e053-2a95a90a4239
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmceuticals,Inc.
- Application
- ANDA204290
- Marketing category
- ANDA
- Marketing start
- 2016-01-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2846-9 | montelukast sodium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2846 | MONTELUKAST SODIUM TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.] | 1 | Legacy NDC, 1 package rows | 20221008_ea764c40-6647-3f9f-e053-2a95a90a4239.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 |
|---|
| 68071-2846-9 | 68071284609 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2846-9) | 2022-10-07 | 0000-00-00 | No | No | Current |