AMLODIPINE BESYLATE
- Product NDC
- 71610-830
- 11-digit product format
- 716100830
- Labeler code
- 71610
- Product ID
- 71610-830_29b99df4-d06a-8ad8-e063-6294a90a2ff4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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 |
|---|
| 71610-830-30 | 71610083030 | 30 TABLET in 1 BOTTLE (71610-830-30) | 30 tablet | 2024-05-13 | No | No | Historical |
| 71610-830-45 | 71610083045 | 45 TABLET in 1 BOTTLE (71610-830-45) | 45 tablet | 2024-05-13 | No | No | Historical |
| 71610-830-60 | 71610083060 | 90 TABLET in 1 BOTTLE (71610-830-60) | 90 tablet | 2024-12-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| AMLODIPINE BESYLATE 10 mg | Aphena Pharma Solutions - Tennessee, LLC | 2024-12-20 | HUMAN PRESCRIPTION DRUG LABEL | 2 |