Gemfibrozil

NDC 68382-553 · Zydus Pharmaceuticals (USA) Inc.

Generic nameGemfibrozil

Dosage formTABLET

RouteORAL

Active ingredient(s)GEMFIBROZIL

Strength600 mg/1

Pharmacologic classPPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]

Marketing categoryANDA

Packages

68382-553-01 100 TABLET in 1 BOTTLE (68382-553-01)

68382-553-05 500 TABLET in 1 BOTTLE (68382-553-05)

68382-553-06 30 TABLET in 1 BOTTLE (68382-553-06)

68382-553-10 1000 TABLET in 1 BOTTLE (68382-553-10)

68382-553-14 60 TABLET in 1 BOTTLE (68382-553-14)

68382-553-16 90 TABLET in 1 BOTTLE (68382-553-16)

68382-553-30 10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

50268-350 — Gemfibrozil, 51655-143 — Gemfibrozil, 60687-224 — Gemfibrozil, 62135-160 — Gemfibrozil, 63187-772 — Gemfibrozil, 65862-624 — Gemfibrozil, 66267-436 — Gemfibrozil, 67046-0233 — Gemfibrozil, 68071-1733 — Gemfibrozil, 68071-2387 — Gemfibrozil, 68788-7964 — Gemfibrozil, 69097-821 — Gemfibrozil, 70518-1563 — Gemfibrozil, 70518-4305 — Gemfibrozil, 70771-1431 — Gemfibrozil, 71209-008 — Gemfibrozil, 71335-0051 — GEMFIBROZIL, 71335-1902 — Gemfibrozil, 71335-1996 — Gemfibrozil, 71335-2025 — Gemfibrozil, +23 more

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