Prescription drug · NDA
Benicar (olmesartan medoxomil) NDC 0713-0862
Olmesartan medoxomil 40 mg/1 · Tablet, Film coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0862-30 | 00713086230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0862-30)Marketed from Sep 1, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Benicar
- Generic name (nonproprietary)
- olmesartan medoxomil
- Active ingredients
- Olmesartan medoxomil — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021286
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0713-0862_00494313-514a-b3b5-e063-6294a90a5ad5SPL ID 00494313-514a-b3b5-e063-6294a90a5ad5SPL set ID 5b6f8a18-8f8a-4521-81c3-3a39c73c6646RxCUI 349373, 349401, 349405, 352199, 352200, 352201UNII 6M97XTV3HDUPC 0307130861304, 0307130862301, 0307130860307
- 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
N400713086230followed by a unit qualifier and the quantityPackage 00713-0862-30. 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)
Benicar 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 Benicar. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy,…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021286
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 |
|---|---|---|---|---|
| Benicarolmesartan medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0940 |
| Benicarolmesartan medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0941 |
| Benicarolmesartan medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0860 |
| Benicarolmesartan medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0942 |
| Benicarolmesartan medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Cosette Pharmaceuticals, Inc. | 0713-0861 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.