Prescription drug · ANDA
Valsartan NDC 53401-033
Valsartan 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-033-81 | 53401003381 | 1080 TABLET in 1 BOTTLE (53401-033-81)Marketed from Sep 1, 2026 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204011
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53401-033_5a816ba8-afd9-bda3-e063-6294a90a16bbSPL ID 5a816ba8-afd9-bda3-e063-6294a90a16bbSPL set ID 5a816ea6-2645-bd6e-e063-6294a90a908bRxCUI 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
N453401003381followed by a unit qualifier and the quantityPackage 53401-0033-81. 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: 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 heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure. ( 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. ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204011
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 | TabletOral | Amneal Pharmaceuticals LLC | 65162-837 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-838 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-839 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-840 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-837 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-838 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-839 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-840 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | AvKARE | 42291-859 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | AvKARE | 42291-856 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | AvKARE | 42291-857 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | AvKARE | 42291-858 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-029 |