What is NDC 72578-133?

72578-133 is the product NDC for Valsartan, Valsartan 160 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valsartan NDC 72578-133 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0133Add 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
72578-133-16	7257801331672578013316	90 TABLET, FILM COATED in 1 BOTTLE (72578-133-16)Marketed from Aug 30, 2024

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 — 160 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218991
Marketing start: Aug 30, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 72578-133_08731c4e-5c0c-4fba-b250-dbd17fd36e6eSPL ID 08731c4e-5c0c-4fba-b250-dbd17fd36e6eSPL set ID bd7b35c7-9f01-4afd-b497-bbe0f3d69b29RxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7IUPC 0372578131067, 0372578134167
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

N472578013316 followed by a unit qualifier and the quantity

Package 72578-0133-16. 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 Jul 23, 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, to lowe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-133

What is NDC 72578-133?: 72578-133 is the product NDC for Valsartan, Valsartan 160 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Valsartan NDCs
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

All 131 Valsartan NDCs

Other NDCs under ANDA 218991

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

FDA NDC Directory listings under ANDA 218991
Product	Strength	Form · route	Labeler	Product NDC
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1882
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1883
Valsartan	Valsartan 160 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1884
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1885
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-131
Valsartan	Valsartan 80 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-132
Valsartan	Valsartan 320 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-134
Valsartan	Valsartan 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-553