Amlodipine Besylate
- Product NDC
- 71610-988
- 11-digit product format
- 716100988
- Labeler code
- 71610
- Product ID
- 71610-988_4a2baf2b-9abf-e333-e063-6294a90a110c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076719
- Marketing category
- ANDA
- Marketing start
- 2007-05-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 308135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-988-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71610-988-45 | Amlodipine Besylate | 45 in 1 BOTTLE | TABLET | 45 | | 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 |
|---|
| 71610-988-30 | 71610098830 | 30 TABLET in 1 BOTTLE (71610-988-30) | 30 tablet | 2026-02-06 | No | No | Historical |
| 71610-988-45 | 71610098845 | 45 TABLET in 1 BOTTLE (71610-988-45) | 45 tablet | 2026-02-06 | No | No | Historical |