Prescription drug · ANDA
Valsartan NDC 50090-6346
Valsartan 320 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6346-0 | 50090634600 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6346-0)Marketed from Jan 25, 2023 | |
| 50090-6346-1 | 50090634601 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6346-1)Marketed from Jan 25, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6346_35890fc6-a455-41c4-82a5-3a8b9e9094c0SPL ID 35890fc6-a455-41c4-82a5-3a8b9e9094c0SPL set ID 0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0RxCUI 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
N450090634600followed by a unit qualifier and the quantityPackage 50090-6346-00. 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 to 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 hypertensio…
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 | Proficient Rx LP | 82804-154 |
| 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 |
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