Pirfenidone

NDC 69238-1641 · Amneal Pharmaceuticals NY LLC

Generic namePirfenidone

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)PIRFENIDONE

Strength801 mg/1

Pharmacologic classPyridone [EPC], Pyridones [CS]

Marketing categoryANDA

Packages

69238-1641-9 — 1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

FDA lists these products with the same active ingredient.

60219-1641 — Pirfenidone, 60219-1642 — Pirfenidone, 60505-4681 — Pirfenidone, 60505-4682 — Pirfenidone, 62332-479 — Pirfenidone, 62332-480 — Pirfenidone, 69097-940 — PIRFENIDONE, 69097-987 — Pirfenidone, 69097-988 — Pirfenidone, 69238-1640 — Pirfenidone, 69238-1642 — Pirfenidone, 70954-869 — Pirfenidone, 70954-870 — Pirfenidone, 71335-2944 — Pirfenidone, 71335-2984 — Pirfenidone, 72162-2465 — Pirfenidone, 72162-2466 — Pirfenidone, 72205-181 — PIRFENIDONE, 72205-182 — PIRFENIDONE, 72603-258 — PIRFENIDONE, +40 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.