Prescription drug · ANDA
Olmesartan Medoxomil NDC 46708-131
Olmesartan medoxomil 5 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-131-10 | 46708013110 | 100 TABLET, FILM COATED in 1 CARTON (46708-131-10)Marketed from Apr 24, 2017 | |
| 46708-131-30 | 46708013130 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-131-30)Marketed from Apr 24, 2017 | |
| 46708-131-90 | 46708013190 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-131-90)Marketed from Apr 24, 2017 | |
| 46708-131-91 | 46708013191 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-131-91)Marketed from Apr 24, 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 203012
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 46708-131_03dfb859-492b-4154-8fc7-dc4fa90cbf59SPL ID 03dfb859-492b-4154-8fc7-dc4fa90cbf59SPL set ID ac08ea7d-f529-42ca-850a-a0ecce7dc830RxCUI 349373, 349401, 349405UNII 6M97XTV3HDUPC 0346708132309, 0346708133306, 0346708131302
- 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
N446708013110followed by a unit qualifier and the quantityPackage 46708-0131-10. 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)
1. INDICATIONS AND USAGE Olmesartan medoxomil is indicated for the treatment of hypertension, 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 management, antithrombotic therapy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203012
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, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-132 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-133 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-133 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-131 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-132 |