Prescription drug · ANDA
Valsartan NDC 31722-748
Valsartan 320 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-748-05 | 31722074805 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-748-05)Marketed from Jan 5, 2015 | |
| 31722-748-30 | 31722074830 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-748-30)Marketed from Jan 5, 2015 | |
| 31722-748-31 | 31722074831 | 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-748-31)Marketed from Jan 5, 2015 | |
| 31722-748-32 | 31722074832 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-748-32)Marketed from Jan 5, 2015 | |
| 31722-748-90 | 31722074890 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-748-90)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 — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- 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 31722-748_2b44fd7a-fd5a-984d-e063-6294a90a3fffSPL ID 2b44fd7a-fd5a-984d-e063-6294a90a3fffSPL set ID 0ff36e83-b307-42db-a2ab-bae3f6805c20RxCUI 349199, 349200, 349201, 349483UNII 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
N431722074805followed by a unit qualifier and the quantityPackage 31722-0748-05. 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 tablet is 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 to 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 infrarction ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to l…
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 |
Showing 20 of 23.