What is NDC 80491-8012?

80491-8012 is the product NDC for Tryvio (aprocitentan), Aprocitentan 12.5 mg/1 tablet, film coated, listed with the FDA by Idorsia Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

Idorsia Pharmaceuticals Ltd, NDC labeler code 80491. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tryvio?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tryvio NDC 80491-8012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80491-8012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80491-8012Add 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
80491-8012-3	80491801203	1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 1, 2024
80491-8012-8	80491801208	1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)Marketed from Mar 20, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Tryvio
Generic name (nonproprietary): aprocitentan
Active ingredients: Aprocitentan — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Idorsia Pharmaceuticals LtdNDC labeler code 80491
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217686
Marketing start: Mar 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 80491-8012_44bb9bce-c692-4295-805a-14aed0e7fb04SPL ID 44bb9bce-c692-4295-805a-14aed0e7fb04SPL set ID dfe7a2ee-612c-4aba-834a-d68e6b59a0a6RxCUI 2679064, 2679070UNII MZI81HV01P
Pharmacologic class: Endothelin Receptor Antagonist

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

N480491801203 followed by a unit qualifier and the quantity

Package 80491-8012-03. 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 Aug 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80491-8012

What is NDC 80491-8012?: 80491-8012 is the product NDC for Tryvio (aprocitentan), Aprocitentan 12.5 mg/1 tablet, film coated, listed with the FDA by Idorsia Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tryvio (Aprocitentan).
What is the active ingredient?: Aprocitentan.
Who is the labeler?: Idorsia Pharmaceuticals Ltd, NDC labeler code 80491. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tryvio?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Tryvio (Aprocitentan) NDC 80491-8012