Prescription drug · NDA
Avapro (irbesartan) NDC 0024-5852
Irbesartan 300 mg/1 · Tablet, Film coated · Oral · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5852-30 | 00024585230 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)Marketed from Jan 1, 2013 |
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)
- Avapro
- Generic name (nonproprietary)
- irbesartan
- Active ingredients
- Irbesartan — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020757
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0024-5852_95417d25-97fb-4082-a659-4a50e8c6c50dSPL ID 95417d25-97fb-4082-a659-4a50e8c6c50dSPL set ID 7885b2a8-be4e-48ab-8113-4e6ab791eb98RxCUI 153666, 153667, 200095, 200096UNII J0E2756Z7NUPC 0300245852304, 0300245851307
- 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
N400024585230followed by a unit qualifier and the quantityPackage 00024-5852-30. 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)
AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension AVAPRO ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020757
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 |
|---|---|---|---|---|
| Avaproirbesartan | Irbesartan 150 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5851 |