Amlodipine Besylate
- Product NDC
- 50090-5354
- 11-digit product format
- 500905354
- Labeler code
- 50090
- Product ID
- 50090-5354_ccb87248-13c9-455b-8e8e-3f21fd381cf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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 |
|---|
| 50090-5354-0 | 50090535400 | 30 TABLET in 1 BOTTLE (50090-5354-0) | 30 tablet | 2020-11-11 | No | No | Historical |
| 50090-5354-1 | 50090535401 | 90 TABLET in 1 BOTTLE (50090-5354-1) | 90 tablet | 2020-11-11 | No | No | Historical |
| 50090-5354-2 | 50090535402 | 100 TABLET in 1 BOTTLE (50090-5354-2) | 100 tablet | 2024-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | A-S Medication Solutions | 2024-10-14 | HUMAN PRESCRIPTION DRUG LABEL | 8 |