Pirfenidone

NDC 46708-480 · Alembic Pharmaceuticals Limited

Generic namePirfenidone

Dosage formTABLET, COATED

RouteORAL

Active ingredient(s)PIRFENIDONE

Strength801 mg/1

Pharmacologic classPyridone [EPC], Pyridones [CS]

Marketing categoryANDA

Packages

46708-480-71 — 500 TABLET, COATED in 1 BOTTLE (46708-480-71)

46708-480-90 — 90 TABLET, COATED in 1 BOTTLE (46708-480-90)

FDA lists these products with the same active ingredient.

42291-490 — Pirfenidone, 42291-491 — Pirfenidone, 42291-492 — Pirfenidone, 42385-923 — Pirfenidone, 42385-924 — Pirfenidone, 42385-925 — Pirfenidone, 42385-926 — Pirfenidone, 42571-335 — Pirfenidone, 42571-336 — Pirfenidone, 46708-479 — Pirfenidone, 50228-441 — PIRFENIDONE, 50228-442 — PIRFENIDONE, 50228-443 — PIRFENIDONE, 50242-122 — PIRFENIDONE, 50242-123 — PIRFENIDONE, 51407-913 — Pirfenidone, 51407-914 — Pirfenidone, 59651-238 — Pirfenidone, 59651-239 — Pirfenidone, 59651-244 — 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.