Prescription drug · ANDA
Valsartan NDC 63187-655
Valsartan 320 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-655-30 | 63187065530 | 30 TABLET in 1 BOTTLE (63187-655-30)Marketed from Dec 1, 2018 | |
| 63187-655-60 | 63187065560 | 60 TABLET in 1 BOTTLE (63187-655-60)Marketed from Dec 1, 2018 | |
| 63187-655-90 | 63187065590 | 90 TABLET in 1 BOTTLE (63187-655-90)Marketed from Dec 1, 2018 |
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 — 320 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-655_0e31e187-683b-437f-91b6-d14cd11882bfSPL ID 0e31e187-683b-437f-91b6-d14cd11882bfSPL set ID b58471fe-e2c6-4cc5-9d49-6a3111f6e002RxCUI 349200UNII 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
N463187065530followed by a unit qualifier and the quantityPackage 63187-0655-30. 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 ) • 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 blood pressure. Lowering blood p…
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 80 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-368 |
| 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 | 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 |