AMLODIPINE BESYLATE
- Product NDC
- 82804-971
- 11-digit product format
- 828040971
- Labeler code
- 82804
- Product ID
- 82804-971_6313edc5-d2d5-44a1-a06f-7f7829c870d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 |
|---|
| 82804-971-00 | 82804097100 | 100 TABLET in 1 BOTTLE (82804-971-00) | 100 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-11 | 82804097111 | 1000 TABLET in 1 BOTTLE (82804-971-11) | 1000 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-30 | 82804097130 | 30 TABLET in 1 BOTTLE (82804-971-30) | 30 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-55 | 82804097155 | 500 TABLET in 1 BOTTLE (82804-971-55) | 500 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-60 | 82804097160 | 60 TABLET in 1 BOTTLE (82804-971-60) | 60 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-72 | 82804097172 | 120 TABLET in 1 BOTTLE (82804-971-72) | 120 tablet | 2025-02-13 | No | No | Historical |
| 82804-971-90 | 82804097190 | 90 TABLET in 1 BOTTLE (82804-971-90) | 90 tablet | 2025-02-13 | No | No | Historical |