Amlodipine Besylate
- Product NDC
- 68180-455
- 11-digit product format
- 681800455
- Labeler code
- 68180
- Product ID
- 68180-455_cc27c9a5-dd2e-4a79-af00-28f51408362a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA078043
- Marketing category
- ANDA
- Marketing start
- 2024-06-12
- 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
- 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 |
|---|
| 68180-455-01 | 68180045501 | 90 TABLET in 1 BOTTLE (68180-455-01) | 90 tablet | 2024-06-24 | No | No | Historical |
| 68180-455-02 | 68180045502 | 1000 TABLET in 1 BOTTLE (68180-455-02) | 1000 tablet | 2024-06-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-04-20 | HUMAN PRESCRIPTION DRUG LABEL | 29 |
| Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-08-22 | HUMAN PRESCRIPTION DRUG LABEL | 27 |