NDC codes

FDA NDC Directory
Product NDC (as listed)59651-494Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0494Add 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 NDC11-digit (billing)PackageCopy
59651-494-305965104943030 TABLET, FILM COATED in 1 BOTTLE (59651-494-30)Marketed from Jul 21, 2022

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
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216531
Marketing start
Listing expires
Other FDA classes
Endothelin Receptor Antagonists (Mechanism)
Identifiers
Product ID 59651-494_a6d48e99-4411-4724-8372-b01692a5dff7SPL ID a6d48e99-4411-4724-8372-b01692a5dff7SPL set ID 82e51c75-fb78-4ad3-8bce-5e0581d60014RxCUI 722116, 722122UNII 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

N459651049430 followed by a unit qualifier and the quantity

Package 59651-0494-30. 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 . 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 to 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) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included trials predominantly in patients with WHO …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-494

What is NDC 59651-494?
59651-494 is the product NDC for ambrisentan, Ambrisentan 5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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?
23 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AmbrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-14182009-0141-30
AmbrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-14282009-0142-30
AmbrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralApotex Corp.60505-455260505-4552-03
AmbrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralApotex Corp.60505-455360505-4553-03
ambrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-767050090-7670-00
ambrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-767150090-7671-00
ambrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-49559651-0495-30
AmbrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-59451407-0594-30
AmbrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-59551407-0595-30
AmbrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralActavis Pharma, Inc.0591-240500591-2405-30

All 24 ambrisentan NDCs

Other NDCs under ANDA 216531

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

FDA NDC Directory listings under ANDA 216531
ProductStrengthForm · routeLabelerProduct NDC
ambrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7670
ambrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7671
ambrisentanAmbrisentan 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-495

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in