Amlodipine Besylate
- Product NDC
- 71335-2507
- 11-digit product format
- 713352507
- Labeler code
- 71335
- Product ID
- 71335-2507_97992e54-4553-4e64-97f8-0d04b6ff3133
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-2507-0 | 71335250700 | 7 TABLET in 1 BOTTLE (71335-2507-0) | 7 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-1 | 71335250701 | 30 TABLET in 1 BOTTLE (71335-2507-1) | 30 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-2 | 71335250702 | 90 TABLET in 1 BOTTLE (71335-2507-2) | 90 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-3 | 71335250703 | 60 TABLET in 1 BOTTLE (71335-2507-3) | 60 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-4 | 71335250704 | 120 TABLET in 1 BOTTLE (71335-2507-4) | 120 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-5 | 71335250705 | 100 TABLET in 1 BOTTLE (71335-2507-5) | 100 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-6 | 71335250706 | 800 TABLET in 1 BOTTLE (71335-2507-6) | 800 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-7 | 71335250707 | 1000 TABLET in 1 BOTTLE (71335-2507-7) | 1000 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-8 | 71335250708 | 180 TABLET in 1 BOTTLE (71335-2507-8) | 180 tablet | 2024-10-07 | No | No | Historical |
| 71335-2507-9 | 71335250709 | 10 TABLET in 1 BOTTLE (71335-2507-9) | 10 tablet | 2024-10-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Bryant Ranch Prepack | 2024-10-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |