Prescription drug · NDA
Azilsartan Medoxomil (azilsartan kamedoxomil) NDC 52536-008
Azilsartan kamedoxomil 80 mg/1 · Tablet · Oral · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-008-03 | 52536000803 | 30 TABLET in 1 BOTTLE (52536-008-03)Marketed from Apr 27, 2026 |
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)
- Azilsartan Medoxomil
- Generic name (nonproprietary)
- azilsartan kamedoxomil
- Active ingredients
- Azilsartan kamedoxomil — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200796
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Type 1 Receptor Antagonists (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 52536-008_c09103d8-c094-473d-a303-bbb4f334aa8cSPL ID c09103d8-c094-473d-a303-bbb4f334aa8cSPL set ID c09103d8-c094-473d-a303-bbb4f334aa8cRxCUI 1091646, 1091652UPC 0352536004039, 0352536008037
- 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
N452536000803followed by a unit qualifier and the quantityPackage 52536-0008-03. 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)
Azilsartan medoxomil is indicated for the treatment of hypertension in adults, 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 azilsartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cess…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 200796
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 |
|---|---|---|---|---|
| Edarbiazilsartan kamedoxomil | Azilsartan kamedoxomil 40 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 60631-040 |
| Edarbiazilsartan kamedoxomil | Azilsartan kamedoxomil 80 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 60631-080 |
| Azilsartan Medoxomilazilsartan kamedoxomil | Azilsartan kamedoxomil 40 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-004 |