Prescription drug · ANDA
Valsartan NDC 67877-416
Valsartan 80 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-416-05 | 67877041605 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-416-05)Marketed from Mar 14, 2019 | |
| 67877-416-10 | 67877041610 | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-416-10)Marketed from Mar 14, 2019 | |
| 67877-416-90 | 67877041690 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-416-90)Marketed from Mar 14, 2019 |
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, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205536
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67877-416_b24a6cf6-a1b4-4d30-8a87-ec5ad793de42SPL ID b24a6cf6-a1b4-4d30-8a87-ec5ad793de42SPL set ID 7b4ecaf9-e84c-4660-9cd1-65a238efd8a8RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0367877418902
- 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
N467877041605followed by a unit qualifier and the quantityPackage 67877-0416-05. 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: 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-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 bl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205536
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 40 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-415 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-417 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-418 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-011 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3165 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-612 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-623 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-634 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-550 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1337 |