Prescription drug · NDA
Avalide (Irbesartan and hydrochlorothiazide) NDC 0024-5855
Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5855-30 | 00024585530 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30)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)
- Avalide
- Generic name (nonproprietary)
- irbesartan and hydrochlorothiazide
- Active ingredients
- Irbesartan — 150 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sanofi-Aventis U.S. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020758
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0024-5855_5f9089ce-2d9c-4077-8774-acd86b5eff4dSPL ID 5f9089ce-2d9c-4077-8774-acd86b5eff4dSPL set ID 0d91895e-c869-4b33-9b83-d55c1ad6317eRxCUI 310792, 310793, 823934, 823938UNII 0J48LPH2TH, J0E2756Z7NUPC 0300245856302, 0300245855305
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
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
N400024585530followed by a unit qualifier and the quantityPackage 00024-5855-30. 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)
AVALIDE ® (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevan…
Excerpt only. Read the full label for complete information.
About NDC 0024-5855
- What is NDC 0024-5855?
- 0024-5855 is the product NDC for Avalide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Avalide (Irbesartan and hydrochlorothiazide).
- What is the active ingredient?
- Irbesartan, Hydrochlorothiazide.
- Who is the labeler?
- Sanofi-Aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Avalide?
- 1 other product NDC are listed under this name. See all Avalide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Avalide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Avalideirbesartan and hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5856 | 00024-5856-30 |
Other NDCs under NDA 020758
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 |
|---|---|---|---|---|
| Avalideirbesartan and hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Sanofi-Aventis U.S. LLC | 0024-5856 |