Prescription drug · ANDA
valsartan NDC 59746-361
Valsartan 80 mg/1 · Tablet · Oral · Jubilant Cadista Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-361-03 | 59746036103 | 10 BLISTER PACK in 1 CARTON (59746-361-03) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 5, 2015 | |
| 59746-361-05 | 59746036105 | 500 TABLET in 1 BOTTLE (59746-361-05)Marketed from Jan 5, 2015 | |
| 59746-361-30 | 59746036130 | 30 TABLET in 1 BOTTLE (59746-361-30)Marketed from Jan 5, 2015 | |
| 59746-361-90 | 59746036190 | 90 TABLET in 1 BOTTLE (59746-361-90)Marketed from Jan 5, 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
- 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 59746-361_1e2b0e94-49d1-44bd-9564-20991a251f5aSPL ID 1e2b0e94-49d1-44bd-9564-20991a251f5aSPL set ID 9402b022-5809-4251-dfef-54f6ef5723feRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0359746360306, 0359746393908, 0359746361303, 0359746362300
- 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
N459746036103followed by a unit qualifier and the quantityPackage 59746-0361-03. 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 angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years 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, to lower b…
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 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 |
| valsartan | Valsartan 320 mg/1 | TabletOral | A-S Medication Solutions | 50090-5192 |