Prescription drug · NDA
Edarbi (Azilsartan kamedoxomil) NDC 60631-040
Azilsartan kamedoxomil 40 mg/1 · Tablet · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60631-040-30 | 6063100403060631004030 | 30 TABLET in 1 BOTTLE (60631-040-30)Marketed from Feb 1, 2013 | |
| 60631-040-77 | 6063100407760631004077 | 7 TABLET in 1 BOTTLE (60631-040-77)Marketed from Feb 1, 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)
- Edarbi
- Generic name (nonproprietary)
- azilsartan kamedoxomil
- Active ingredients
- Azilsartan kamedoxomil — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 60631
- 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 60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9deSPL ID 2f63b0e8-977a-4d22-9550-29ad1926a9deSPL set ID 52b27c75-9f5a-4816-bafd-dace9d7d2063RxCUI 1091646, 1091650, 1091652, 1091654UPC 0360631080308, 0360631040302
- 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
N460631004030followed by a unit qualifier and the quantityPackage 60631-0040-30. 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)
Edarbi 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 Edarbi. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited…
Excerpt only. Read the full label for complete information.
About NDC 60631-040
- What is NDC 60631-040?
- 60631-040 is the product NDC for Edarbi (azilsartan kamedoxomil), Azilsartan kamedoxomil 40 mg/1 tablet, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Edarbi (Azilsartan kamedoxomil).
- What is the active ingredient?
- Azilsartan kamedoxomil.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 60631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Edarbi?
- 1 other product NDC are listed under this name. See all Edarbi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Edarbi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Edarbiazilsartan kamedoxomil | Azilsartan kamedoxomil 80 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 60631-080 | 60631-0080-3060631-0080-77 |
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 |
|---|---|---|---|---|
| Azilsartan Medoxomilazilsartan kamedoxomil | Azilsartan kamedoxomil 40 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-004 |
| Azilsartan Medoxomilazilsartan kamedoxomil | Azilsartan kamedoxomil 80 mg/1 | TabletOral | Wilshire Pharmaceuticals, Inc. | 52536-008 |
| Edarbiazilsartan kamedoxomil | Azilsartan kamedoxomil 80 mg/1 | TabletOral | Azurity Pharmaceuticals, Inc. | 60631-080 |