Prescription drug · ANDA
Valsartan NDC 50228-135
Valsartan 40 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-135-10 | 5022801351050228013510 | 1000 TABLET in 1 BOTTLE (50228-135-10)Marketed from Oct 27, 2021 | |
| 50228-135-30 | 5022801353050228013530 | 30 TABLET in 1 BOTTLE (50228-135-30)Marketed from Oct 27, 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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, INC.NDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204038
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50228-135_32318eee-6c28-4ec7-8a20-2089c6bd33ebSPL ID 32318eee-6c28-4ec7-8a20-2089c6bd33ebSPL set ID 1a8af3d9-4053-4233-82a7-e8c7bc9e302fRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0350228134309, 0350228133302, 0350228135108, 0350228133906, 0350228132909, 0350228135306, 0350228134903, 0350228132305
- 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
N450228013510followed by a unit qualifier and the quantityPackage 50228-0135-10. 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 tablets are indicated for the treatment of hypertension, to lower blood p…
Excerpt only. Read the full label for complete information.
About NDC 50228-135
- What is NDC 50228-135?
- 50228-135 is the product NDC for Valsartan, Valsartan 40 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals, INC.. It has 2 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?
- ScieGen Pharmaceuticals, INC., NDC labeler code 50228. 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 204038
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 320 mg/1 | TabletOral | ScieGen Pharmaceuticals, INC. | 50228-132 |
| Valsartan | Valsartan 160 mg/1 | TabletOral | ScieGen Pharmaceuticals, INC. | 50228-133 |
| Valsartan | Valsartan 80 mg/1 | TabletOral | ScieGen Pharmaceuticals, INC. | 50228-134 |