What is NDC 0378-4271?

0378-4271 is the product NDC for Ambrisentan, Ambrisentan 10 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-4271 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4271Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4271Add 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
0378-4271-93	0037842719300378427193	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4271-93)Marketed from Apr 29, 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208441
Marketing start: Apr 29, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-4271_e6cdba8a-c9be-460b-918a-f72bd6310bceSPL ID e6cdba8a-c9be-460b-918a-f72bd6310bceSPL set ID 8080b009-361b-4505-b09a-0d91a0e4a2c0RxCUI 722116, 722122UNII HW6NV07QECUPC 0303784270936, 0303784271933
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

N400378427193 followed by a unit qualifier and the quantity

Package 00378-4271-93. 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 Dec 5, 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 tablets are 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 patient…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-4271

What is NDC 0378-4271?: 0378-4271 is the product NDC for Ambrisentan, Ambrisentan 10 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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

Other NDCs under ANDA 208441

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

FDA NDC Directory listings under ANDA 208441
Product	Strength	Form · route	Labeler	Product NDC
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4270