Amlodipine Besylate
- Product NDC
- 71610-888
- 11-digit product format
- 716100888
- Labeler code
- 71610
- Product ID
- 71610-888_313fd56f-b10b-b499-e063-6294a90a2912
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076846
- Marketing category
- ANDA
- Marketing start
- 2023-06-22
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 71610-888-15 | 71610088815 | 15 TABLET in 1 BOTTLE (71610-888-15) | 15 tablet | 2025-03-20 | No | No | Historical |
| 71610-888-30 | 71610088830 | 30 TABLET in 1 BOTTLE (71610-888-30) | 30 tablet | 2025-03-20 | No | No | Historical |
| 71610-888-45 | 71610088845 | 45 TABLET in 1 BOTTLE (71610-888-45) | 45 tablet | 2025-03-20 | No | No | Historical |
| 71610-888-60 | 71610088860 | 90 TABLET in 1 BOTTLE (71610-888-60) | 90 tablet | 2025-03-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Aphena Pharma Solutions - Tennessee, LLC | 2025-03-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |