Prescription drug · NDA
Diovan (Valsartan) NDC 0078-1259
Valsartan 320 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1259-34 | 0007812593400078125934 | 90 TABLET in 1 BOTTLE (0078-1259-34)Marketed from Jul 21, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Diovan
- Generic name (nonproprietary)
- valsartan
- Active ingredients
- Valsartan — 320 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021283
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0078-1259_8b57e357-5cfb-49a6-a600-59ce118fd1e9SPL ID 8b57e357-5cfb-49a6-a600-59ce118fd1e9SPL set ID 5ddba454-f3e6-43c2-a7a6-58365d297213RxCUI 349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274UNII 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
N400078125934followed by a unit qualifier and the quantityPackage 00078-1259-34. 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)
Diovan 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 Diovan ® is indicated for the treatment of hypertension, to lower blood pressure in a…
Excerpt only. Read the full label for complete information.
About NDC 0078-1259
- What is NDC 0078-1259?
- 0078-1259 is the product NDC for Diovan (valsartan), Valsartan 320 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diovan (Valsartan).
- What is the active ingredient?
- Valsartan.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diovan?
- 6 other product NDCs are listed under this name. See all Diovan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diovan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diovanvalsartan | Valsartan 80 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0358 | 00078-0358-34 |
| Diovanvalsartan | Valsartan 160 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0359 | 00078-0359-34 |
| Diovanvalsartan | Valsartan 320 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0360 | 00078-0360-34 |
| Diovanvalsartan | Valsartan 40 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0423 | 00078-0423-15 |
| Diovanvalsartan | Valsartan 80 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1245 | 00078-1245-34 |
| Diovanvalsartan | Valsartan 160 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1252 | 00078-1252-34 |
Other NDCs under NDA 021283
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 |
|---|---|---|---|---|
| Diovanvalsartan | Valsartan 80 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0358 |
| Diovanvalsartan | Valsartan 160 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0359 |
| Diovanvalsartan | Valsartan 320 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0360 |
| Diovanvalsartan | Valsartan 40 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0423 |
| Diovanvalsartan | Valsartan 80 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1245 |
| Diovanvalsartan | Valsartan 160 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1252 |