Letairis (ambrisentan) NDC 61958-0802

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-0802Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-0802Add 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
61958-0802-1	61958080201	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0802-1)Marketed from Jun 15, 2007
61958-0802-2	61958080202	3 BLISTER PACK in 1 CARTON (61958-0802-2) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 15, 2007
61958-0802-3	61958080203	1 BLISTER PACK in 1 CARTON (61958-0802-3) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 15, 2007
61958-0802-5	61958080205	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0802-5)Marketed from Jun 15, 2007

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): Letairis
Generic name (nonproprietary): ambrisentan
Active ingredients: Ambrisentan — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Gilead Sciences, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022081
Marketing start: Jun 15, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 61958-0802_2808f55e-aed5-40c7-832b-630e1408951cSPL ID 2808f55e-aed5-40c7-832b-630e1408951cSPL set ID 725d4e73-6c83-477a-adc6-0ae4a133a844RxCUI 722116, 722120, 722122, 722124UNII HW6NV07QEC
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

N461958080201 followed by a unit qualifier and the quantity

Package 61958-0802-01. 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 Jun 22, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies (14.2) ]. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022081

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

FDA NDC Directory listings under NDA 022081
Product	Strength	Form · route	Labeler	Product NDC
Letairisambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Gilead Sciences, Inc.	61958-0801