Prescription drug · NDA
Lotrel NDC 0078-0405
amlodipine besylate and benazepril hydrochloride · Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0405-05 | 00078040505 | 100 CAPSULE in 1 BOTTLE (0078-0405-05)Marketed from Mar 3, 1995 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lotrel
- Generic name (nonproprietary)
- amlodipine besylate and benazepril hydrochloride
- Active ingredients
- Amlodipine besylate — 5 mg/1Benazepril hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020364
- Marketing start
- Marketing end
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 0078-0405_b9db75d9-9d1e-4b2d-9876-5f5520feaeccSPL ID b9db75d9-9d1e-4b2d-9876-5f5520feaeccSPL set ID 94ae6054-b7ae-4212-a567-4f803af8f2c7RxCUI 898342, 898344, 898346, 898348, 898353, 898355, 898356, 898358UNII N1SN99T69T, 864V2Q084H
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400078040505followed by a unit qualifier and the quantityPackage 00078-0405-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lotrel is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. ( 1 ) 1.1 Hypertension Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020364
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lotrelamlodipine besylate and benazepril hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0379 |
| Lotrelamlodipine besylate and benazepril hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0406 |
| Lotrelamlodipine besylate and benazepril hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0364 |