Amlodipine Besylate and Benazepril Hydrochloride
- Product NDC
- 68788-8818
- 11-digit product format
- 687888818
- Labeler code
- 68788
- Product ID
- 68788-8818_7c75fa72-9b0f-44bf-a745-dfa647ed1e78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078466
- Marketing category
- ANDA
- Marketing start
- 2025-01-15
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 10; 20 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], 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 and Benazepril Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
| BENAZEPRIL HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 864V2Q084H, N1SN99T69T |
| Rxcui | 898342 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 864V2Q084H | AMLODIPINE BESYLATE | 111470-99-6 | AMLODIPINE BESYLATE |
| N1SN99T69T | BENAZEPRIL HYDROCHLORIDE | 86541-74-4 | BENAZEPRIL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8818-3 | 68788881803 | 30 CAPSULE in 1 BOTTLE (68788-8818-3) | 30 capsule | 2025-01-15 | No | No | Current |