Pirfenidone Capsule, 267 mg NDC 33342-461

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0461Add 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
33342-461-38	33342046138	1 BLISTER PACK in 1 CARTON (33342-461-38) / 63 CAPSULE in 1 BLISTER PACKMarketed from Jul 20, 2020
33342-461-58	33342046158	270 CAPSULE in 1 BOTTLE (33342-461-58)Marketed from Jul 20, 2020
33342-461-82	33342046182	1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACKMarketed from Jul 20, 2020

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 Capsule, 267 mg
Generic name (nonproprietary): pirfenidone capsule, 267 mg
Active ingredients: Pirfenidone — 267 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212748
Marketing start: Jul 20, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Pyridones (Chemical structure)
Identifiers: Product ID 33342-461_3e8acd31-bbc7-48d5-956d-6cb04cbdc96cSPL ID 3e8acd31-bbc7-48d5-956d-6cb04cbdc96cSPL set ID 3e8acd31-bbc7-48d5-956d-6cb04cbdc96cRxCUI 1592279UNII D7NLD2JX7UUPC 0333342461353, 0333342461360, 0333342461582, 0333342461827, 0333342461384, 0333342461810
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

N433342046138 followed by a unit qualifier and the quantity

Package 33342-0461-38. 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 Mar 28, 2025.

Indications (excerpt from the label)

Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone capsules are 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)