Ambrisentan NDC 69097-386

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-386Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0386Add 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
69097-386-02	69097038602	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-386-02)Marketed from Apr 26, 2019
69097-386-19	69097038619	1 BLISTER PACK in 1 CARTON (69097-386-19) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 26, 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: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210715
Marketing start: Apr 26, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 69097-386_7921a3aa-6e99-4f28-a5d3-a3047b1ec3ccSPL ID 7921a3aa-6e99-4f28-a5d3-a3047b1ec3ccSPL set ID 0e418384-cae1-47ae-ac5e-afc845d694f6RxCUI 722116, 722122UNII HW6NV07QECUPC 0369097387020, 0369097386023
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

N469097038602 followed by a unit qualifier and the quantity

Package 69097-0386-02. 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 Apr 22, 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. 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 tablet is 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 with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210715

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

FDA NDC Directory listings under ANDA 210715
Product	Strength	Form · route	Labeler	Product NDC
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-387