Prescription drug · ANDA
Valsartan NDC 51655-456
Valsartan 160 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-456-52 | 51655045652 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-456-52)Marketed from Oct 23, 2020 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202696
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51655-456_490ef62b-2445-2161-e063-6294a90a748dSPL ID 490ef62b-2445-2161-e063-6294a90a748dSPL set ID f305e9d7-341a-45f6-e053-2a95a90a2d69RxCUI 349201UNII 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
N451655045652followed by a unit qualifier and the quantityPackage 51655-0456-52. 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 tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 6 years 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-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,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202696
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 320 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-301 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4130 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-063 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-062 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-064 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-065 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-049 |