Amlodipine Besylate
- Product NDC
- 53002-3351
- 11-digit product format
- 530023351
- Labeler code
- 53002
- Product ID
- 53002-3351_286895ac-9aea-48f7-9337-d365e60f8285
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 864V2Q084H | AMLODIPINE BESYLATE | 111470-99-6 | AMLODIPINE BESYLATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3351-0 | 53002335100 | 100 TABLET in 1 BOTTLE (53002-3351-0) | 100 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-3351-3 | 53002335103 | 30 TABLET in 1 BOTTLE (53002-3351-3) | 30 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-3351-6 | 53002335106 | 60 TABLET in 1 BOTTLE (53002-3351-6) | 60 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | RPK Pharmaceuticals, Inc. | 2022-03-30 | Human Prescription Drug Label | 4 |