Prescription drug · ANDA
Valsartan NDC 65862-572
Valsartan 160 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-572-10 | 65862057210 | 10 BLISTER PACK in 1 CARTON (65862-572-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 5, 2015 | |
| 65862-572-90 | 65862057290 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-572-90)Marketed from Jan 5, 2015 | |
| 65862-572-99 | 65862057299 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-572-99)Marketed from Jan 5, 2015 |
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)
- Valsartan
- Generic name (nonproprietary)
- valsartan
- Active ingredients
- Valsartan — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202223
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65862-572_7b329c09-5c17-4117-9cef-a383ecec90d9SPL ID 7b329c09-5c17-4117-9cef-a383ecec90d9SPL set ID a81a72dd-e828-4208-af9b-bb9ac4938537RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7I
- 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
N465862057210followed by a unit qualifier and the quantityPackage 65862-0572-10. 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)
Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II to IV), to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower bloo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202223
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 |
|---|---|---|---|---|
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-570 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-571 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-573 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.