Amlodipine Besylate
- Product NDC
- 68788-4085
- 11-digit product format
- 687884085
- Labeler code
- 68788
- Product ID
- 68788-4085_a6635bb3-b8d5-4046-ac56-27af9bac877e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078043
- Marketing category
- ANDA
- Marketing start
- 2026-02-26
- 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
- 2027-12-31
- 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 |
|---|
| 68788-4085-1 | 68788408501 | 100 TABLET in 1 BOTTLE (68788-4085-1) | 100 tablet | 2026-02-26 | No | No | Historical |
| 68788-4085-3 | 68788408503 | 30 TABLET in 1 BOTTLE (68788-4085-3) | 30 tablet | 2026-02-26 | No | No | Historical |
| 68788-4085-6 | 68788408506 | 60 TABLET in 1 BOTTLE (68788-4085-6) | 60 tablet | 2026-02-26 | No | No | Historical |
| 68788-4085-9 | 68788408509 | 90 TABLET in 1 BOTTLE (68788-4085-9) | 90 tablet | 2026-02-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Preferred Pharmaceuticals Inc. | 2026-02-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |