Esbriet (pirfenidone) NDC 83107-028

NDC codes

FDA NDC Directory

Product NDC (as listed)83107-028Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83107-0028Add 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
83107-028-27	83107002827	1 BOTTLE, PLASTIC in 1 CARTON (83107-028-27) / 270 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 31, 2025 · Sample package

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): Esbriet
Generic name (nonproprietary): pirfenidone
Active ingredients: Pirfenidone — 267 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Legacy Pharma USA Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208780
Marketing start: May 31, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 83107-028_372827fa-ccfe-42b6-e063-6394a90af5e8SPL ID 372827fa-ccfe-42b6-e063-6394a90af5e8SPL set ID 81f17f7d-cb04-4052-8682-dd3e330210abRxCUI 1868014, 1868016, 1868018, 1868020UNII D7NLD2JX7U
Pharmacologic class: Pyridone

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

N483107002827 followed by a unit qualifier and the quantity

Package 83107-0028-27. 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 Jun 9, 2025.

Indications (excerpt from the label)

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208780

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

FDA NDC Directory listings under NDA 208780
Product	Strength	Form · route	Labeler	Product NDC
Esbrietpirfenidone	Pirfenidone 267 mg/1	Tablet, CoatedOral	Genentech, Inc.	50242-122
Esbrietpirfenidone	Pirfenidone 801 mg/1	Tablet, CoatedOral	Genentech, Inc.	50242-123
Esbrietpirfenidone	Pirfenidone 801 mg/1	Tablet, CoatedOral	Legacy Pharma USA Inc.	83107-029