Amlodipine Besylate
- Product NDC
- 43489-102
- 11-digit product format
- 434890102
- Labeler code
- 43489
- Product ID
- 43489-102_b9ca151f-09b2-1c00-e053-2a95a90a0f86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- China Resources Saike Pharmaceutical Co., Ltd.
- Application
- ANDA090752
- Marketing category
- ANDA
- Marketing start
- 2011-04-15
- 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
- 2022-12-31
- 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 |
|---|
| 43489-102-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0e39-0266-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, for oral adminstration Initial U.S. Approval: 1992 |
| 43489-102-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0e39-0266-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, for oral adminstration Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43489-102-01 | Amlodipine Besylate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 24 |
| 43489-102-10 | Amlodipine Besylate | 300 in 1 BOTTLE, PLASTIC | TABLET | 300 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43489-102 | AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD.] | 24 | Legacy NDC, 2 package rows | 20210127_3518853a-4c5b-4161-a178-8da7f656f009.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 |
|---|
| 43489-102-01 | 43489010201 | 90 TABLET in 1 BOTTLE, PLASTIC (43489-102-01) | 90 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |
| 43489-102-10 | 43489010210 | 300 TABLET in 1 BOTTLE, PLASTIC (43489-102-10) | 300 tablet | 2016-05-23 | 0000-00-00 | No | No | Current |