NDC codes

FDA NDC Directory
Product NDC (as listed)50242-122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50242-0122Add 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
50242-122-06502420122061 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) / 270 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 22, 2018

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
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208780
Marketing start
Marketing end
Other FDA classes
Pyridones (Chemical structure)
Identifiers
Product ID 50242-122_86848f3d-1ab2-457b-9f36-eba22bea36ddSPL ID 86848f3d-1ab2-457b-9f36-eba22bea36ddSPL set ID 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6eRxCUI 1592279, 1592285, 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

N450242012206 followed by a unit qualifier and the quantity

Package 50242-0122-06. 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 .

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
ProductStrengthForm · routeLabelerProduct NDC
EsbrietpirfenidonePirfenidone 801 mg/1Tablet, CoatedOralGenentech, Inc.50242-123
EsbrietpirfenidonePirfenidone 267 mg/1Tablet, CoatedOralLegacy Pharma USA Inc.83107-028
EsbrietpirfenidonePirfenidone 801 mg/1Tablet, CoatedOralLegacy Pharma USA Inc.83107-029

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