Ambrisentan NDC 60505-4552

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4552Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4552Add 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
60505-4552-3	60505455203	30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)Marketed from Sep 19, 2022

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): Ambrisentan
Generic name (nonproprietary): ambrisentan
Active ingredients: Ambrisentan — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210701
Marketing start: Sep 19, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 60505-4552_2950aca0-011d-ea24-bbd4-4557a0fe1aecSPL ID 2950aca0-011d-ea24-bbd4-4557a0fe1aecSPL set ID 291a782a-77e1-8a8e-e1c8-2626f305c2b7RxCUI 722116, 722122UNII HW6NV07QECUPC 0360505455232, 0360505455331
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

N460505455203 followed by a unit qualifier and the quantity

Package 60505-4552-03. 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 Sep 3, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. 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%). Ambrisentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included trials predominantly in patients wit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210701

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

FDA NDC Directory listings under ANDA 210701
Product	Strength	Form · route	Labeler	Product NDC
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-594
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-595
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4553