Prescription drug · ANDA
Valsartan NDC 82804-154
Valsartan 160 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-154-30 | 82804015430 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-154-30)Marketed from Feb 18, 2025 | |
| 82804-154-90 | 82804015490 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-154-90)Marketed from Oct 3, 2024 |
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
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203311
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 82804-154_c64664c5-0981-4086-a933-c9c46d34167fSPL ID c64664c5-0981-4086-a933-c9c46d34167fSPL set ID f59f71d3-c143-43e5-ac22-0b1d741f4a81RxCUI 349201UNII 80M03YXJ7IUPC 0382804154906
- 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
N482804015430followed by a unit qualifier and the quantityPackage 82804-0154-30. 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: • 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 ( Error! Hyperlink reference not valid. ) • Heart failure (NYHA class II to IV), to reduce hospitalization for heart failure in adults ( Error! Hyperlink reference not valid. ) • 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 ( Error! Hyperlink re…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203311
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 160 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6348 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-010 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-153 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-151 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-152 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-154 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2152 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2151 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2154 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2155 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1574 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1596 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-749 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-746 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-747 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-748 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-834 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-745 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-746 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-747 |
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