Ambrisentan NDC 42794-051

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0051Add 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
42794-051-08	42794005108	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08)Marketed from Apr 10, 2019
42794-051-22	42794005122	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22)Marketed from Apr 10, 2019

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): Ambrisentan
Generic name (nonproprietary): ambrisentan
Active ingredients: Ambrisentan — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sigmapharm Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208354
Marketing start: Apr 10, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 42794-051_f1f20771-a78f-74cf-e053-2995a90a6adfSPL ID f1f20771-a78f-74cf-e053-2995a90a6adfSPL set ID e20ab2fe-bc9f-48a3-b15a-e4bc9532c2acRxCUI 722116, 722122UNII HW6NV07QECUPC 0342794052088, 0342794051081
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

N442794005108 followed by a unit qualifier and the quantity

Package 42794-0051-08. 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 Jan 10, 2023. 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): 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) (WHO Group 1): To imp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208354

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

FDA NDC Directory listings under ANDA 208354
Product	Strength	Form · route	Labeler	Product NDC
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Sigmapharm Laboratories, LLC	42794-052