AMLODIPINE BESYLATE
- Product NDC
- 53002-1352
- 11-digit product format
- 530021352
- Labeler code
- 53002
- Product ID
- 53002-1352_83b797a3-41c9-46d1-91dd-6d7768885ba4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077073
- Marketing category
- ANDA
- Marketing start
- 2007-09-26
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- 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 |
|---|
| 53002-1352-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-0 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-0 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
| 53002-1352-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-430f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1352-0 | AMLODIPINE BESYLATE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 53002-1352-3 | AMLODIPINE BESYLATE | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1352 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE TABLET [RPK PHARMACEUTICALS, INC.] | 8 | Legacy NDC, 2 package rows | 20230609_16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a.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 |
|---|
| 53002-1352-0 | 53002135200 | 100 TABLET in 1 BOTTLE (53002-1352-0) | 100 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1352-3 | 53002135203 | 30 TABLET in 1 BOTTLE (53002-1352-3) | 30 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |