Prescription drug · ANDA
Amlodipine and Olmesartan Medoxomil NDC 42291-001
Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-001-30 | 42291000130 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-001-30)Marketed from Jun 18, 2024 |
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 and Olmesartan Medoxomil
- Generic name (nonproprietary)
- amlodipine and olmesartan medoxomil
- Active ingredients
- Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209010
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 42291-001_48480a71-5c94-91ab-e063-6294a90a656dSPL ID 48480a71-5c94-91ab-e063-6294a90a656dSPL set ID 1b30c3fe-5c84-0d42-e063-6394a90a81d8RxCUI 730861, 730866, 730869, 730872UNII 864V2Q084H, 6M97XTV3HDUPC 0342291003309, 0342291002302, 0342291004306, 0342291001305
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; 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
N442291000130followed by a unit qualifier and the quantityPackage 42291-0001-30. 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 olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209010
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 and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-366 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-365 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-367 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-368 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2673 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2676 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2674 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2675 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-004 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-002 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-003 |