Amlodipine Besylate
- Product NDC
- 68071-3698
- 11-digit product format
- 680713698
- Labeler code
- 68071
- Product ID
- 68071-3698_37774bf3-6b24-06e6-e063-6294a90a5966
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078043
- Marketing category
- ANDA
- Marketing start
- 2018-08-15
- 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 |
|---|
| 68071-3698-2 | 68071369802 | 120 TABLET in 1 BOTTLE (68071-3698-2) | 120 tablet | 2025-01-21 | No | No | Historical |
| 68071-3698-6 | 68071369806 | 60 TABLET in 1 BOTTLE (68071-3698-6) | 60 tablet | 2024-10-11 | No | No | Historical |
| 68071-3698-9 | 68071369809 | 90 TABLET in 1 BOTTLE (68071-3698-9) | 90 tablet | 2024-10-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | NuCare Pharmaceuticals,Inc. | 2025-06-13 | HUMAN PRESCRIPTION DRUG LABEL | 3 |