Prescription drug · ANDA
valsartan NDC 50090-5192
Valsartan 320 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5192-0 | 50090519200 | 30 TABLET in 1 BOTTLE (50090-5192-0)Marketed from Sep 29, 2020 | |
| 50090-5192-1 | 50090519201 | 90 TABLET in 1 BOTTLE (50090-5192-1)Marketed from Sep 29, 2020 |
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
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203536
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-5192_5b2ec706-d7b6-4c25-a7b6-a8db54e0fa29SPL ID 5b2ec706-d7b6-4c25-a7b6-a8db54e0fa29SPL set ID 80987771-ccb4-4a9f-a395-0af4c2621e0aRxCUI 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
N450090519200followed by a unit qualifier and the quantityPackage 50090-5192-00. 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 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 ) Post-myocardial infarction; for the 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203536
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 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-281 |
| valsartan | Valsartan 40 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-360 |
| valsartan | Valsartan 80 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-361 |
| valsartan | Valsartan 160 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-362 |
| valsartan | Valsartan 320 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-393 |
| valsartan | Valsartan 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-695 |
| valsartan | Valsartan 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-5190 |
| valsartan | Valsartan 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-5191 |