Prescription drug · ANDA
Valsartan NDC 72336-910
Valsartan 4 mg/mL · Solution · Oral · Lifsa Drugs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72336-910-79 | 72336091079 | 120 mL in 1 BOTTLE, PLASTIC (72336-910-79)Marketed from Apr 4, 2022 | |
| 72336-910-89 | 72336091089 | 473 mL in 1 BOTTLE, PLASTIC (72336-910-89)Marketed from Apr 4, 2022 |
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 — 4 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Lifsa Drugs LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214102
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72336-910_dd4cbd3f-572e-400b-8fe7-98d537557b80SPL ID dd4cbd3f-572e-400b-8fe7-98d537557b80SPL set ID 130e1659-9c2d-49ca-9db8-d28aa23fd133RxCUI 1996254UNII 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
N472336091079followed by a unit qualifier and the quantityPackage 72336-0910-79. 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 in adults and children six years and older, to lower blood pressure. 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); Valsartan oral solution significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets (1.2) Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Valsartan oral solution reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets (1.3) 1.1 Hypertension Val…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214102
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 4 mg/mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-310 |
- openFDA data updated
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