Prescription drug · ANDA
Amlodipine and olmesartan Medoxomil NDC 67877-502
Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-502-30 | 67877050230 | 30 TABLET in 1 BOTTLE (67877-502-30)Marketed from Aug 14, 2017 | |
| 67877-502-90 | 67877050290 | 90 TABLET in 1 BOTTLE (67877-502-90)Marketed from Aug 14, 2017 |
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 — 10 mg/1Olmesartan medoxomil — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209042
- 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 67877-502_32238052-6c4c-4b29-a59e-524c819c69f1SPL ID 32238052-6c4c-4b29-a59e-524c819c69f1SPL set ID c1204fbe-d086-43cf-bbaa-efec9cd0487cRxCUI 730861, 730866, 730869, 730872UNII 864V2Q084H, 6M97XTV3HD
- 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
N467877050230followed by a unit qualifier and the quantityPackage 67877-0502-30. 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 is 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 209042
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 10 mg/1; Olmesartan medoxomil 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-500 |
| Amlodipine and olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-499 |
| Amlodipine and olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-501 |