Amlodipine Besylate
- Product NDC
- 70518-4464
- 11-digit product format
- 705184464
- Labeler code
- 70518
- Product ID
- 70518-4464_3de4ec88-b525-d5a5-e063-6294a90ab368
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2025-09-03
- 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
- 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 | 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 |
|---|
| 70518-4464-0 | Amlodipine Besylate | 90 in 1 BOTTLE, PLASTIC | 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 |
|---|
| 70518-4464-0 | 70518446400 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4464-0) | 90 tablet | 2025-09-03 | No | No | Historical |