Amlodipine Besylate
- Product NDC
- 72189-529
- 11-digit product format
- 721890529
- Labeler code
- 72189
- Product ID
- 72189-529_39ab6651-a795-ad78-e063-6294a90a8a8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2023-12-14
- 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 |
|---|
| 72189-529-30 | 72189052930 | 30 TABLET in 1 BOTTLE (72189-529-30) | 30 tablet | 2023-12-14 | No | No | Historical |
| 72189-529-90 | 72189052990 | 90 TABLET in 1 BOTTLE (72189-529-90) | 90 tablet | 2023-12-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Direct_Rx | 2025-07-11 | HUMAN PRESCRIPTION DRUG LABEL | 3 |