Montelukast Sodium
- Product NDC
- 60723-010
- 11-digit product format
- 607230010
- Labeler code
- 60723
- Product ID
- 60723-010_a622c4f1-3ecc-eb59-e053-2995a90a8def
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hangzhou Minsheng Binjiang Pharm
- Application
- ANDA205683
- Marketing category
- ANDA
- Marketing start
- 2016-05-30
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 60723-010-03 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-09 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-50 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-03 | 2020-06-02 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-09 | 2020-06-02 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-50 | 2020-06-02 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
| 60723-010-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-db2c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60723-010-03 | Montelukast Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 60723-010-09 | Montelukast Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 60723-010-50 | Montelukast Sodium | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60723-010 | MONTELUKAST SODIUM TABLET [HANGZHOU MINSHENG BINJIANG PHARM] | 3 | Legacy NDC, 3 package rows | 20200527_7223644e-a5cc-498f-8cf4-7d3f20231389.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 |
|---|
| 60723-010-03 | 60723001003 | 30 TABLET in 1 BOTTLE (60723-010-03) | 30 tablet | 2021-05-31 | 0000-00-00 | No | No | Current |
| 60723-010-09 | 60723001009 | 90 TABLET in 1 BOTTLE (60723-010-09) | 90 tablet | 2021-05-31 | 0000-00-00 | No | No | Current |
| 60723-010-50 | 60723001050 | 500 TABLET in 1 BOTTLE (60723-010-50) | 500 tablet | 2021-05-31 | 0000-00-00 | No | No | Current |