Amlodipine Besylate
- Product NDC
- 71335-2359
- 11-digit product format
- 713352359
- Labeler code
- 71335
- Product ID
- 71335-2359_31134e23-cb5c-4ce1-9a09-f8222eab9b9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2019-05-22
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361 |
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 |
|---|
| 71335-2359-0 | 71335235900 | 5 TABLET in 1 BOTTLE, PLASTIC (71335-2359-0) | 5 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-1 | 71335235901 | 30 TABLET in 1 BOTTLE, PLASTIC (71335-2359-1) | 30 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-2 | 71335235902 | 90 TABLET in 1 BOTTLE, PLASTIC (71335-2359-2) | 90 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-3 | 71335235903 | 60 TABLET in 1 BOTTLE, PLASTIC (71335-2359-3) | 60 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-4 | 71335235904 | 100 TABLET in 1 BOTTLE, PLASTIC (71335-2359-4) | 100 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-5 | 71335235905 | 180 TABLET in 1 BOTTLE, PLASTIC (71335-2359-5) | 180 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-6 | 71335235906 | 120 TABLET in 1 BOTTLE, PLASTIC (71335-2359-6) | 120 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-7 | 71335235907 | 10 TABLET in 1 BOTTLE, PLASTIC (71335-2359-7) | 10 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-8 | 71335235908 | 500 TABLET in 1 BOTTLE, PLASTIC (71335-2359-8) | 500 tablet | 2024-03-05 | No | No | Current |
| 71335-2359-9 | 71335235909 | 1000 TABLET in 1 BOTTLE, PLASTIC (71335-2359-9) | 1000 tablet | 2024-03-05 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Bryant Ranch Prepack | 2024-03-05 | HUMAN PRESCRIPTION DRUG LABEL | 100 |