Amlodipine Besylate
- Product NDC
- 53002-2351
- 11-digit product format
- 530022351
- Labeler code
- 53002
- Product ID
- 53002-2351_fbb517ce-83e1-4adc-a32e-c00a45050a1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2014-03-03
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2351-0 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 53002-2351-3 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2351 | AMLODIPINE BESYLATE TABLET [RPK PHARMACEUTICALS, INC.] | 6 | Legacy NDC, 2 package rows | 20201217_2db18372-0600-480f-8551-533b61415abd.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 |
|---|
| 53002-2351-0 | 53002235100 | 100 TABLET in 1 BOTTLE (53002-2351-0) | 100 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2351-3 | 53002235103 | 30 TABLET in 1 BOTTLE (53002-2351-3) | 30 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |