Prescription drug · ANDA
Amlodipine Besylate and Benazepril Hydrochloride NDC 55111-339
Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 · Capsule · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-339-01 | 55111033901 | 100 CAPSULE in 1 BOTTLE (55111-339-01)Marketed from Apr 19, 2010 | |
| 55111-339-05 | 55111033905 | 500 CAPSULE in 1 BOTTLE (55111-339-05)Marketed from Apr 19, 2010 | |
| 55111-339-30 | 55111033930 | 30 CAPSULE in 1 BOTTLE (55111-339-30)Marketed from Apr 19, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Amlodipine Besylate and Benazepril Hydrochloride
- 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
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077183
- Marketing start
- Listing expires
- 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 55111-339_6fafdf6a-6153-9a62-1774-755f2bcf0cc2SPL ID 6fafdf6a-6153-9a62-1774-755f2bcf0cc2SPL set ID ca014f06-982c-6fe1-9948-a3701dd35d34RxCUI 898342, 898350, 898353, 898356UNII 864V2Q084H, N1SN99T69TUPC 0355111339014, 0355111340010
- 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
N455111033901followed by a unit qualifier and the quantityPackage 55111-0339-01. 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)
Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. ( 1 ) 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are 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 ANDA 077183
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 |
|---|---|---|---|---|
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4499 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-041 |
| Amlodipine Besylate and Benazepril Hydrochloride | Benazepril hydrochloride 20 mg/1; Amlodipine besylate 5 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-201 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 2.5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Dr.Reddy's Laboratories Limited | 55111-338 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Dr.Reddy's Laboratories Limited | 55111-340 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Dr.Reddy's Laboratories Limited | 55111-341 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5137 |