NDC codes

FDA NDC Directory
Product NDC (as listed)47335-237Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0237Add 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
47335-237-64473350237643 BLISTER PACK in 1 CARTON (47335-237-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)Marketed from Apr 29, 2019
47335-237-66473350237661 BLISTER PACK in 1 CARTON (47335-237-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)Marketed from Apr 29, 2019
47335-237-834733502378330 TABLET, FILM COATED in 1 BOTTLE (47335-237-83)Marketed from Apr 29, 2019
47335-237-854733502378510 TABLET, FILM COATED in 1 BOTTLE (47335-237-85)Marketed from Apr 29, 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210784
Marketing start
Listing expires
Other FDA classes
Endothelin Receptor Antagonists (Mechanism)
Identifiers
Product ID 47335-237_294580cb-5622-4f48-89a8-99000a7a2964SPL ID 294580cb-5622-4f48-89a8-99000a7a2964SPL set ID a4978a54-1799-43d6-85dd-05fa9de0a5d7RxCUI 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

N447335023764 followed by a unit qualifier and the quantity

Package 47335-0237-64. 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 is 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 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 Functional…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-237

What is NDC 47335-237?
47335-237 is the product NDC for ambrisentan, Ambrisentan 10 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-49459651-0494-30
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

All 24 ambrisentan NDCs

Other NDCs under ANDA 210784

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

FDA NDC Directory listings under ANDA 210784
ProductStrengthForm · routeLabelerProduct NDC
ambrisentanAmbrisentan 5 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-236

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