NDC codes

FDA NDC Directory
Product NDC (as listed)72205-181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72205-0181Add 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
72205-181-2672205018126722050181263 BOTTLE in 1 CARTON (72205-181-26) / 90 TABLET, FILM COATED in 1 BOTTLE (72205-181-90)Marketed from Sep 8, 2022
72205-181-3672205018136722050181363 BOTTLE in 1 CARTON (72205-181-36) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)Marketed from Sep 8, 2022
72205-181-3872205018138722050181389 BOTTLE in 1 CARTON (72205-181-38) / 30 TABLET, FILM COATED in 1 BOTTLE (72205-181-30)Marketed from Sep 8, 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)
Pirfenidone
Generic name (nonproprietary)
pirfenidone
Active ingredients
Pirfenidone — 267 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Novadoz Pharmaceuticals LLCNDC labeler code 72205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212772
Marketing start
Listing expires
Other FDA classes
Pyridones (Chemical structure)
Identifiers
Product ID 72205-181_2e84fe0d-424b-472b-938a-ef317ed61a79SPL ID 2e84fe0d-424b-472b-938a-ef317ed61a79SPL set ID 741d1b9c-e281-4eca-b327-e25e82313006RxCUI 1868014, 1868018UNII D7NLD2JX7UUPC 0372205181304, 0372205182905, 0372205181267, 0372205181908, 0372205182301
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

N472205018126 followed by a unit qualifier and the quantity

Package 72205-0181-26. 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)

Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone tablet 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)

About NDC 72205-181

What is NDC 72205-181?
72205-181 is the product NDC for Pirfenidone, Pirfenidone 267 mg/1 tablet, film coated, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pirfenidone.
What is the active ingredient?
Pirfenidone.
Who is the labeler?
Novadoz Pharmaceuticals LLC, NDC labeler code 72205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pirfenidone?
54 other product NDCs are listed under this name. See all Pirfenidone 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 Pirfenidone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PirfenidonePirfenidone 267 mg/1CapsuleOralAurobindo Pharma Limited59651-24459651-0244-2759651-0244-2859651-0244-42
PirfenidonePirfenidone 267 mg/1TabletOralAurobindo Pharma Limited59651-23859651-0238-27
PirfenidonePirfenidone 801 mg/1TabletOralAurobindo Pharma Limited59651-23959651-0239-90
PirfenidonePirfenidone 267 mg/1TabletOralApotex Corp.60505-468160505-4681-0760505-4681-09
PirfenidonePirfenidone 801 mg/1TabletOralApotex Corp.60505-468260505-4682-09
PirfenidonePirfenidone 267 mg/1CapsuleOralAvKARE42291-49042291-0490-27
PirfenidonePirfenidone 267 mg/1Tablet, Film coatedOralAvKARE42291-49142291-0491-27
PirfenidonePirfenidone 801 mg/1Tablet, Film coatedOralAvKARE42291-49242291-0492-09
PirfenidonePirfenidone 267 mg/1TabletOralGolden State Medical Supply, Inc.51407-91351407-0913-27
PirfenidonePirfenidone 801 mg/1TabletOralGolden State Medical Supply, Inc.51407-91451407-0914-90

All 55 Pirfenidone NDCs

Other NDCs under ANDA 212772

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

FDA NDC Directory listings under ANDA 212772
ProductStrengthForm · routeLabelerProduct NDC
PirfenidonePirfenidone 267 mg/1Tablet, Film coatedOralMAJOR PHARMACEUTICALS0904-7397
PirfenidonePirfenidone 801 mg/1Tablet, Film coatedOralMAJOR PHARMACEUTICALS0904-7398
PirfenidonePirfenidone 801 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-182
PirfenidonePirfenidone 267 mg/1Tablet, Film coatedOralNorthstar Rx LLC72603-258
PirfenidonePirfenidone 801 mg/1Tablet, Film coatedOralNorthstar Rx LLC72603-259

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