Amiodarone hydrochloride

NDC 68083-112 · Gland Pharma Limited

Generic nameAmiodarone hydrochloride

Dosage formINJECTION, SOLUTION

RouteINTRAVENOUS

Active ingredient(s)AMIODARONE HYDROCHLORIDE

Strength50 mg/mL

Pharmacologic classAntiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

Marketing categoryANDA

Packages

68083-112-01 — 10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

62135-578 — Amiodarone Hydrochloride, 63323-616 — AMIODARONE HYDROCHLORIDE, 65219-643 — AMIODARONE HYDROCHLORIDE, 65219-645 — AMIODARONE HYDROCHLORIDE, 65841-631 — Amiodarone hydrochloride, 65841-840 — Amiodarone hydrochloride, 65841-841 — Amiodarone hydrochloride, 65862-732 — Amiodarone Hydrochloride, 67296-2296 — Amiodarone Hydrochloride, 67457-153 — amiodarone hydrochloride, 68382-227 — amiodarone hydrochloride, 68382-297 — amiodarone hydrochloride, 68382-298 — amiodarone hydrochloride, 70436-232 — amiodarone hydrochloride, 70518-1231 — Amiodarone Hydrochloride, 70518-1939 — Amiodarone Hydrochloride, 70518-3246 — Amiodarone Hydrochloride, 70518-3439 — Amiodarone Hydrochloride, 71335-0881 — Amiodarone Hydrochloride, 71335-1942 — Amiodarone Hydrochloride, +51 more

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