Pirfenidone

NDC 76282-716 · EXELAN PHARMACEUTICALS INC.

Generic namePirfenidone

Dosage formTABLET, COATED

RouteORAL

Active ingredient(s)PIRFENIDONE

Strength801 mg/1

Pharmacologic classPyridone [EPC], Pyridones [CS]

Marketing categoryANDA

Packages

76282-716-27 — 270 TABLET, COATED in 1 BOTTLE (76282-716-27)

76282-716-90 — 90 TABLET, COATED in 1 BOTTLE (76282-716-90)

FDA lists these products with the same active ingredient.

69097-940 — PIRFENIDONE, 69097-987 — Pirfenidone, 69097-988 — Pirfenidone, 69238-1640 — Pirfenidone, 69238-1641 — 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, 72603-259 — PIRFENIDONE, 76282-715 — PIRFENIDONE, 76282-717 — Pirfenidone, 83107-028 — PIRFENIDONE, 83107-029 — PIRFENIDONE, +40 more

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.