Amlodipine Besylate and Benazepril Hydrochloride
- Product NDC
- 71335-2634
- 11-digit product format
- 713352634
- Labeler code
- 71335
- Product ID
- 71335-2634_d38d8624-94b7-4595-a3d8-776e48c33755
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078466
- Marketing category
- ANDA
- Marketing start
- 2010-02-05
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 5; 10 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
openFDA Listing Details
- Product ID
- 71335-2634_d38d8624-94b7-4595-a3d8-776e48c33755
- SPL ID
- d38d8624-94b7-4595-a3d8-776e48c33755
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate and Benazepril Hydrochloride
- Generic name
- Amlodipine Besylate and Benazepril Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2010-02-05
- Marketing category
- ANDA
- Application number
- ANDA078466
- 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]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| BENAZEPRIL HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 864V2Q084H, N1SN99T69T |
| Rxcui | 898353 |
| Spl Set Id | d058e426-8786-4fd3-a771-992e4558c135 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2634-1 | 30 CAPSULE in 1 BOTTLE (71335-2634-1) | 2025-06-02 | No |
| 71335-2634-2 | 90 CAPSULE in 1 BOTTLE (71335-2634-2) | 2025-06-02 | No |
| 71335-2634-3 | 60 CAPSULE in 1 BOTTLE (71335-2634-3) | 2025-06-02 | No |
| 71335-2634-4 | 100 CAPSULE in 1 BOTTLE (71335-2634-4) | 2025-06-02 | No |
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 |
|---|
| 71335-2634-1 | 71335263401 | 30 CAPSULE in 1 BOTTLE (71335-2634-1) | 30 capsule | 2025-06-02 | No | No | Historical |
| 71335-2634-2 | 71335263402 | 90 CAPSULE in 1 BOTTLE (71335-2634-2) | 90 capsule | 2025-06-02 | No | No | Historical |
| 71335-2634-3 | 71335263403 | 60 CAPSULE in 1 BOTTLE (71335-2634-3) | 60 capsule | 2025-06-02 | No | No | Historical |
| 71335-2634-4 | 71335263404 | 100 CAPSULE in 1 BOTTLE (71335-2634-4) | 100 capsule | 2025-06-02 | No | No | Historical |