Amlodipine Besylate
- Product NDC
- 83008-035
- 11-digit product format
- 830080035
- Labeler code
- 83008
- Product ID
- 83008-035_32b4fbba-6ca8-465d-88eb-19fe414a5c85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2023-07-20
- Marketing end
- 2027-02-28
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 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
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-035-30 | 83008003530 | 30 TABLET in 1 BOTTLE, PLASTIC (83008-035-30) | 30 tablet | 2023-07-20 | 2027-02-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Quality Care Products, LLC | 2024-12-19 | HUMAN PRESCRIPTION DRUG LABEL | 4 |