Amlodipine Besylate
- Product NDC
- 71610-732
- 11-digit product format
- 716100732
- Labeler code
- 71610
- Product ID
- 71610-732_4f9271e4-d2e6-4456-a890-69d43dcf7496
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076846
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 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 table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-732-15 | Amlodipine Besylate | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 71610-732-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71610-732-45 | Amlodipine Besylate | 45 in 1 BOTTLE | TABLET | 45 | | 1 |
| 71610-732-53 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71610-732-60 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-732 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, 5 package rows | 20230910_d830173d-7676-4490-ab3d-d3515df9ad2e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-732-15 | 71610073215 | 15 TABLET in 1 BOTTLE (71610-732-15) | 15 tablet | 2023-09-06 | No | No | Historical |
| 71610-732-30 | 71610073230 | 30 TABLET in 1 BOTTLE (71610-732-30) | 30 tablet | 2023-09-06 | No | No | Historical |
| 71610-732-45 | 71610073245 | 45 TABLET in 1 BOTTLE (71610-732-45) | 45 tablet | 2023-09-06 | No | No | Historical |
| 71610-732-53 | 71610073253 | 60 TABLET in 1 BOTTLE (71610-732-53) | 60 tablet | 2023-09-06 | No | No | Historical |
| 71610-732-60 | 71610073260 | 90 TABLET in 1 BOTTLE (71610-732-60) | 90 tablet | 2023-09-06 | No | No | Historical |