Valsartan NDC 0378-5814

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5814Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5814Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-5814-77	00378581477	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5814-77)Marketed from Jan 5, 2015

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): Valsartan
Generic name (nonproprietary): valsartan
Active ingredients: Valsartan — 160 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090866
Marketing start: Jan 5, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-5814_a5384d58-48c7-494a-a8a8-c296b316bd91SPL ID a5384d58-48c7-494a-a8a8-c296b316bd91SPL set ID 73e01dc6-7dd4-421a-a4f6-137e75f69f9aRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0303785815778, 0303785813774, 0303785807933, 0303785814771
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

N400378581477 followed by a unit qualifier and the quantity

Package 00378-5814-77. 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 May 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Valsartan tablets are 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, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090866

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090866
Product	Strength	Form · route	Labeler	Product NDC
Valsartan	Valsartan 160 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-244
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5807
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5813
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5815