Prescription drug · ANDA
Olmesartan Medoxomil NDC 64980-603
Olmesartan medoxomil 40 mg/1 · Tablet, Coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-603-03 | 64980060303 | 30 TABLET, COATED in 1 BOTTLE (64980-603-03)Marketed from Mar 30, 2024 | |
| 64980-603-09 | 64980060309 | 90 TABLET, COATED in 1 BOTTLE (64980-603-09)Marketed from Mar 30, 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)
- Olmesartan Medoxomil
- Generic name (nonproprietary)
- olmesartan medoxomil
- Active ingredients
- Olmesartan medoxomil — 40 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208659
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64980-603_4e8b4338-7c4c-4af4-8658-660111a8b966SPL ID 4e8b4338-7c4c-4af4-8658-660111a8b966SPL set ID b02ff20e-3f0e-43f4-a7b5-6ce56295d023RxCUI 349373, 349401, 349405UNII 6M97XTV3HDUPC 0364980601092, 0364980603034, 0364980601030, 0364980602037, 0364980602099, 0364980603096
- Pharmacologic class
- Angiotensin 2 Receptor 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
N464980060303followed by a unit qualifier and the quantityPackage 64980-0603-03. 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)
Olmesartan medoxomil tablet are indicated for the treatment of hypertension, in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208659
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 |
|---|---|---|---|---|
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, CoatedOral | Rising Pharma Holdings, Inc. | 64980-602 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, CoatedOral | Rising Pharma Holdings, Inc. | 64980-665 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2996 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, CoatedOral | Inventia Healthcare Limited | 49252-065 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, CoatedOral | Inventia Healthcare Limited | 49252-066 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, CoatedOral | Inventia Healthcare Limited | 49252-067 |