Prescription drug · ANDA
Valsartan NDC 43547-368
Valsartan 80 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-368-03 | 43547036803 | 30 TABLET in 1 BOTTLE (43547-368-03)Marketed from Aug 31, 2015 | |
| 43547-368-09 | 43547036809 | 90 TABLET in 1 BOTTLE (43547-368-09)Marketed from Aug 31, 2015 | |
| 43547-368-11 | 43547036811 | 1000 TABLET in 1 BOTTLE (43547-368-11)Marketed from Aug 31, 2015 | |
| 43547-368-50 | 43547036850 | 500 TABLET in 1 BOTTLE (43547-368-50)Marketed from Aug 31, 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204821
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43547-368_bd8fb4f2-9d4a-4cf3-8b9e-cc5ba34bcea1SPL ID bd8fb4f2-9d4a-4cf3-8b9e-cc5ba34bcea1SPL set ID 26080940-bcd3-446d-9026-3ddfb58e281eRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0343547370039, 0343547369033, 0343547368098, 0343547370091, 0343547367039, 0343547368036, 0343547369095
- 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
N443547036803followed by a unit qualifier and the quantityPackage 43547-0368-03. 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 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-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, t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204821
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 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-2424 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2248 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-367 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-369 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-370 |
| Valsartan | Valsartan 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2308 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | A-S Medication Solutions | 50090-7312 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Proficient Rx LP | 63187-655 |
| Valsartan | Valsartan 320 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0475 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-653 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0567 |