Prescription drug · ANDA
Amlodipine Besylate and Benazepril Hydrochloride NDC 55111-586
Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 · Capsule · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-586-01 | 5511105860155111058601 | 100 CAPSULE in 1 BOTTLE (55111-586-01)Marketed from Jul 5, 2011 | |
| 55111-586-05 | 5511105860555111058605 | 500 CAPSULE in 1 BOTTLE (55111-586-05)Marketed from Jul 5, 2011 | |
| 55111-586-30 | 5511105863055111058630 | 30 CAPSULE in 1 BOTTLE (55111-586-30)Marketed from Jul 5, 2011 |
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 — 10 mg/1Benazepril hydrochloride — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090149
- 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 55111-586_2b57e667-c854-2ed1-32f9-b06c6fea1930SPL ID 2b57e667-c854-2ed1-32f9-b06c6fea1930SPL set ID f12f18bb-7ddb-e7dc-4edd-32f4ac212bcaRxCUI 898346, 898359UNII 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
N455111058601followed by a unit qualifier and the quantityPackage 55111-0586-01. 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.
About NDC 55111-586
- What is NDC 55111-586?
- 55111-586 is the product NDC for Amlodipine Besylate and Benazepril Hydrochloride, Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 capsule, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine Besylate and Benazepril Hydrochloride.
- What is the active ingredient?
- Amlodipine besylate, Benazepril hydrochloride.
- Who is the labeler?
- Dr.Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amlodipine Besylate and Benazepril Hydrochloride?
- 47 other product NDCs are listed under this name. See all Amlodipine Besylate and Benazepril Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine Besylate and Benazepril Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 2.5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2684 | 69238-2684-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2685 | 69238-2685-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2686 | 69238-2686-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2687 | 69238-2687-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4499 | 70518-4499-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4386 | 70518-4386-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4388 | 70518-4388-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4382 | 70518-4382-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8818 | 68788-8818-03 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-041 | 82868-0041-90 |
All 48 Amlodipine Besylate and Benazepril Hydrochloride NDCs
Other NDCs under ANDA 090149
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 40 mg/1 | CapsuleOral | Dr.Reddy's Laboratories Limited | 55111-587 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4388 |