AMLODIPINE BESYLATE
- Product NDC
- 71610-985
- 11-digit product format
- 716100985
- Labeler code
- 71610
- Product ID
- 71610-985_49104c85-4322-3bb3-e063-6394a90a350e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMLODIPINE BESYLATE
- Brand name suffix
- 5 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-985-60 | AMLODIPINE BESYLATE5 mg | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-985-60 | 71610098560 | 90 TABLET in 1 BOTTLE (71610-985-60) | 90 tablet | 2026-01-22 | No | No | Current |