Amlodipine Besylate
- Product NDC
- 71610-539
- 11-digit product format
- 716100539
- Labeler code
- 71610
- Product ID
- 71610-539_882a3c50-8604-4230-aeb5-9b9df2f02a15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2019-05-22
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71610-539_882a3c50-8604-4230-aeb5-9b9df2f02a15
- SPL ID
- 882a3c50-8604-4230-aeb5-9b9df2f02a15
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Generic name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2019-05-22
- Marketing category
- ANDA
- Application number
- ANDA203245
- Pharmacologic classes
- Calcium Channel Antagonists [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361 |
| Spl Set Id | afcffa7b-03b7-499a-b50c-37b0e28c7737 |
| Manufacturer Name | Aphena Pharma Solutions - Tennessee, LLC |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71610-539-60 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-539-60) | 2021-04-07 | No |
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 |
|---|
| 71610-539-60 | 71610053960 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-539-60) | 90 tablet | 2021-04-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amlodipine Besylate | Aphena Pharma Solutions - Tennessee, LLC | 2021-05-11 | HUMAN PRESCRIPTION DRUG LABEL | 1 |