Prescription drug · ANDA
Olmesartan Medoxomil NDC 70756-809
Olmesartan medoxomil 20 mg/1 · Tablet · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-809-30 | 70756080930 | 30 TABLET in 1 BOTTLE (70756-809-30)Marketed from May 1, 2020 | |
| 70756-809-90 | 70756080990 | 90 TABLET in 1 BOTTLE (70756-809-90)Marketed from May 1, 2020 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lifestar Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207135
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70756-809_45810d23-5c40-8cba-e063-6294a90a8e9cSPL ID 45810d23-5c40-8cba-e063-6294a90a8e9cSPL set ID a337a621-bf57-4aa4-8224-4356fa2cdbc4RxCUI 349373, 349401, 349405UNII 6M97XTV3HD
- 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
N470756080930followed by a unit qualifier and the quantityPackage 70756-0809-30. 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)
1. INDICATIONS AND USAGE Olmesartan medoxomil is 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 tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207135
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 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-808 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-810 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-009 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-010 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-011 |