Amlodipine besylate
- Product NDC
- 43353-251
- 11-digit product format
- 433530251
- Labeler code
- 43353
- Product ID
- 43353-251_61983438-c773-41d9-a411-59f53ea0901a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077955
- Marketing category
- ANDA
- Marketing start
- 2007-11-02
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 43353-251-15 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4089-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987 |
| 43353-251-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4089-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987 |
| 43353-251-45 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4089-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987 |
| 43353-251-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4089-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-251-15 | Amlodipine besylate | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 43353-251-30 | Amlodipine besylate | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 43353-251-45 | Amlodipine besylate | 45 in 1 BOTTLE | TABLET | 45 | | 5 |
| 43353-251-60 | Amlodipine besylate | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-251 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 5 | Legacy NDC, 4 package rows | 20191228_a1d358b5-c206-463a-a364-18551da8c4e6.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 |
|---|
| 43353-251-15 | 43353025115 | 15 TABLET in 1 BOTTLE (43353-251-15) | 15 tablet | 2017-02-16 | 0000-00-00 | No | No | Current |
| 43353-251-30 | 43353025130 | 30 TABLET in 1 BOTTLE (43353-251-30) | 30 tablet | 2017-02-16 | 0000-00-00 | No | No | Current |
| 43353-251-45 | 43353025145 | 45 TABLET in 1 BOTTLE (43353-251-45) | 45 tablet | 2016-11-04 | 0000-00-00 | No | No | Current |
| 43353-251-60 | 43353025160 | 90 TABLET in 1 BOTTLE (43353-251-60) | 90 tablet | 2017-01-13 | 0000-00-00 | No | No | Current |