sirolimus

NDC 68382-520 · Zydus Pharmaceuticals USA Inc.

Generic namesirolimus

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)SIROLIMUS

Strength.5 mg/1

Pharmacologic classDecreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]

Marketing categoryANDA

Packages

68382-520-01 — 100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01)

68382-520-05 — 500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)

68382-520-06 — 30 TABLET, FILM COATED in 1 BOTTLE (68382-520-06)

68382-520-10 — 1000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10)

68382-520-16 — 90 TABLET, FILM COATED in 1 BOTTLE (68382-520-16)

68382-520-77 — 10 BLISTER PACK in 1 CARTON (68382-520-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-520-30)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

65841-771 — sirolimus, 65841-772 — sirolimus, 65841-773 — sirolimus, 66689-347 — Sirolimus, 67877-746 — Sirolimus, 67877-747 — Sirolimus, 67877-748 — Sirolimus, 68084-915 — Sirolimus, 68382-351 — sirolimus, 68382-352 — sirolimus, 68462-682 — sirolimus, 68462-683 — sirolimus, 68462-684 — sirolimus, 69238-1594 — SIrolimus, 70518-3546 — Sirolimus, 70518-3795 — Sirolimus, 70518-4376 — sirolimus, 70518-4449 — sirolimus, 72162-2641 — sirolimus, 72205-099 — sirolimus, +18 more

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