Prescription drug · ANDA
Olmesartan Medoxomil NDC 68462-436
Olmesartan medoxomil 5 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-436-10 | 68462043610 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-436-10)Marketed from May 25, 2017 | |
| 68462-436-30 | 68462043630 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-436-30)Marketed from May 25, 2017 | |
| 68462-436-90 | 68462043690 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-436-90)Marketed from May 25, 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)
- Olmesartan Medoxomil
- Generic name (nonproprietary)
- olmesartan medoxomil
- Active ingredients
- Olmesartan medoxomil — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203281
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68462-436_3d590efe-ccb3-4ca3-b49e-9547dd674eaeSPL ID 3d590efe-ccb3-4ca3-b49e-9547dd674eaeSPL set ID 8e0adf3d-7569-4909-bab1-5fed9578ad77RxCUI 349373, 349401, 349405UNII 6M97XTV3HDUPC 0368462438305, 0368462437308, 0368462436301
- 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
N468462043610followed by a unit qualifier and the quantityPackage 68462-0436-10. 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 tablets 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 tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, d…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203281
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 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4451 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2376 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7810 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-438 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-437 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6686 |