Prescription drug · ANDA
Valsartan NDC 42385-989
Valsartan 40 mg/1 · Tablet, Film coated · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-989-05 | 4238509890542385098905 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-989-05)Marketed from Apr 22, 2026 | |
| 42385-989-30 | 4238509893042385098930 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-989-30)Marketed from Apr 22, 2026 | |
| 42385-989-68 | 4238509896842385098968 | 10 BLISTER PACK in 1 CARTON (42385-989-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-989-10)Marketed from Apr 22, 2026 |
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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Laurus Labs LimitedNDC labeler code 42385
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218897
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 42385-989_6e1f63ad-e554-421b-a699-4e8c9bd4d239SPL ID 6e1f63ad-e554-421b-a699-4e8c9bd4d239SPL set ID 6e1f63ad-e554-421b-a699-4e8c9bd4d239RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0342385990300, 0342385992304
- 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
N442385098905followed by a unit qualifier and the quantityPackage 42385-0989-05. 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 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 is indicated for the treatment of hypertension, to lower blood pre…
Excerpt only. Read the full label for complete information.
About NDC 42385-989
- What is NDC 42385-989?
- 42385-989 is the product NDC for Valsartan, Valsartan 40 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 3 package NDCs, 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?
- Laurus Labs Limited, NDC labeler code 42385. 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 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 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1884 | 70771-1884-09 |
Other NDCs under ANDA 218897
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 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-990 |
| Valsartan | Valsartan 160 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-991 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-992 |