Prescription drug · ANDA
Valsartan NDC 53746-837
Valsartan 40 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-837-05 | 53746083705 | 500 TABLET in 1 BOTTLE (53746-837-05)Marketed from Aug 1, 2023 | |
| 53746-837-30 | 53746083730 | 30 TABLET in 1 BOTTLE (53746-837-30)Marketed from Aug 1, 2023 | |
| 53746-837-60 | 53746083760 | 60 TABLET in 1 BOTTLE (53746-837-60)Marketed from Aug 1, 2023 |
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 53746-837_254b9473-bbcb-4780-a182-ba287b886a47SPL ID 254b9473-bbcb-4780-a182-ba287b886a47SPL set ID f13587f8-76cb-49ad-9291-5907249d6b8eRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0353746840905, 0353746838902, 0353746837301
- 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
N453746083705followed by a unit qualifier and the quantityPackage 53746-0837-05. 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, to…
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 | Aphena Pharma Solutions - Tennessee, LLC | 53401-033 |
| 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 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 |