What is NDC 0591-2405?

0591-2405 is the product NDC for Ambrisentan, Ambrisentan 5 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ambrisentan?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ambrisentan NDC 0591-2405 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2405Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2405Add 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
0591-2405-30	0059124053000591240530	30 TABLET, FILM COATED in 1 BOTTLE (0591-2405-30)Marketed from Apr 30, 2019

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): Ambrisentan
Generic name (nonproprietary): ambrisentan
Active ingredients: Ambrisentan — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208252
Marketing start: Apr 30, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 0591-2405_67758125-7c3e-4b62-8cb3-e17d7f079322SPL ID 67758125-7c3e-4b62-8cb3-e17d7f079322SPL set ID 32549c43-f8ff-422c-b42d-ca0877e661cfRxCUI 722116, 722122UNII HW6NV07QECUPC 0305912406309, 0305912405302
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

N400591240530 followed by a unit qualifier and the quantity

Package 00591-2405-30. 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 30, 2025. 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. 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%). Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (W…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-2405

What is NDC 0591-2405?: 0591-2405 is the product NDC for Ambrisentan, Ambrisentan 5 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ambrisentan.
What is the active ingredient?: Ambrisentan.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ambrisentan?: 22 other product NDCs are listed under this name. See all Ambrisentan 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 Ambrisentan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-141	82009-0141-30
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-142	82009-0142-30
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4552	60505-4552-03
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4553	60505-4553-03
ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7670	50090-7670-00
ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7671	50090-7671-00
ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-494	59651-0494-30
ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-495	59651-0495-30
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-594	51407-0594-30
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-595	51407-0595-30

All 23 Ambrisentan NDCs