Prescription drug · ANDA
valsartan NDC 51655-695
Valsartan 160 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-695-52 | 5165506955251655069552 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-695-52)Marketed from Mar 23, 2021 |
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 — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- 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 51655-695_4b92fa04-fa06-11ac-e063-6294a90a8da8SPL ID 4b92fa04-fa06-11ac-e063-6294a90a8da8SPL set ID db4801e5-6e0f-2cb3-e053-2995a90a709aRxCUI 349201UNII 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
N451655069552followed by a unit qualifier and the quantityPackage 51655-0695-52. 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)
1INDICATIONS AND USAGE 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 hypert…
Excerpt only. Read the full label for complete information.
About NDC 51655-695
- What is NDC 51655-695?
- 51655-695 is the product NDC for valsartan, Valsartan 160 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- valsartan.
- What is the active ingredient?
- Valsartan.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for valsartan?
- 130 other product NDCs are listed under this name. See all valsartan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other valsartan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| valsartan | Valsartan 320 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-393 | 59746-0393-3059746-0393-3259746-0393-67+1 more |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-989 | 42385-0989-0542385-0989-3042385-0989-68 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-990 | 42385-0990-0542385-0990-3042385-0990-68+1 more |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-991 | 42385-0991-0542385-0991-3042385-0991-68+1 more |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-992 | 42385-0992-0542385-0992-3042385-0992-68+1 more |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1596 | 67046-1596-03 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1574 | 67046-1574-03 |
| Valsartanvalsartan oral | Valsartan 4 mg/mL | SolutionOral | Advagen Pharma Ltd | 72888-184 | 72888-0184-1372888-0184-48 |
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1882 | 70771-1882-03 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1883 | 70771-1883-09 |
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 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 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 72789-281 |