NDC 52584-153

Amiodarone Hydrochloride

Amiodarone Hydrochloride

Amiodarone Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Amiodarone Hydrochloride.

Product ID52584-153_062b7831-e18a-4dc8-9e63-886e950167e0
NDC52584-153
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone Hydrochloride
Generic NameAmiodarone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-03-24
Marketing CategoryANDA /
Application NumberANDA076217
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesAntiarrhythmic [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]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52584-153-03

1 VIAL, SINGLE-DOSE in 1 BAG (52584-153-03) > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2021-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-153-03 [52584015303]

Amiodarone Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076217
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-06
Marketing End Date2015-11-01

Drug Details

NDC Crossover Matching brand name "Amiodarone Hydrochloride" or generic name "Amiodarone Hydrochloride"

NDCBrand NameGeneric Name
0143-9875Amiodarone HydrochlorideAmiodarone Hydrochloride
0185-0144Amiodarone HydrochlorideAmiodarone Hydrochloride
0404-9815Amiodarone HydrochlorideAmiodarone Hydrochloride
0615-4545Amiodarone HydrochlorideAmiodarone Hydrochloride
0615-8213Amiodarone hydrochlorideAmiodarone hydrochloride
0615-8258Amiodarone HydrochlorideAmiodarone Hydrochloride
0904-6556Amiodarone hydrochlorideAmiodarone hydrochloride
0904-6993Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-843Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-844Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-845Amiodarone HydrochlorideAmiodarone Hydrochloride
21695-796Amiodarone hydrochlorideAmiodarone hydrochloride
25021-302amiodarone hydrochlorideamiodarone hydrochloride
29300-359Amiodarone HydrochlorideAmiodarone Hydrochloride
42291-118Amiodarone HydrochlorideAmiodarone Hydrochloride
42291-139Amiodarone HydrochlorideAmiodarone Hydrochloride
68083-112Amiodarone hydrochlorideAmiodarone hydrochloride
68084-371AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
68382-227Amiodarone hydrochlorideAmiodarone hydrochloride
70518-1231Amiodarone HydrochlorideAmiodarone Hydrochloride
70518-1939Amiodarone HydrochlorideAmiodarone Hydrochloride
70518-1571Amiodarone hydrochlorideAmiodarone hydrochloride
71335-0881Amiodarone HydrochlorideAmiodarone Hydrochloride
71872-7149Amiodarone HydrochlorideAmiodarone Hydrochloride
71872-7000Amiodarone HydrochlorideAmiodarone Hydrochloride
50090-2308Amiodarone hydrochlorideAmiodarone hydrochloride
50090-3015Amiodarone HydrochlorideAmiodarone Hydrochloride
50090-3496Amiodarone HydrochlorideAmiodarone Hydrochloride
51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
51672-4025Amiodarone HydrochlorideAmiodarone Hydrochloride
51862-240Amiodarone HydrochlorideAmiodarone Hydrochloride
51672-4057Amiodarone HydrochlorideAmiodarone Hydrochloride
51672-4056Amiodarone HydrochlorideAmiodarone Hydrochloride
51862-242Amiodarone HydrochlorideAmiodarone Hydrochloride
51672-4055Amiodarone HydrochlorideAmiodarone Hydrochloride
51862-241Amiodarone HydrochlorideAmiodarone Hydrochloride
52584-616Amiodarone HydrochlorideAmiodarone Hydrochloride
52584-063AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
53808-1066Amiodarone hydrochlorideAmiodarone hydrochloride
55150-180Amiodarone HydrochlorideAmiodarone Hydrochloride
55154-4996AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
55150-182Amiodarone HydrochlorideAmiodarone Hydrochloride
55154-5492Amiodarone HydrochlorideAmiodarone Hydrochloride
55150-181Amiodarone HydrochlorideAmiodarone Hydrochloride
55648-780Amiodarone HydrochlorideAmiodarone Hydrochloride
55648-739Amiodarone HydrochlorideAmiodarone Hydrochloride
60505-2658Amiodarone HydrochlorideAmiodarone Hydrochloride
63323-616Amiodarone HydrochlorideAmiodarone Hydrochloride
63629-7300Amiodarone hydrochlorideAmiodarone hydrochloride
63739-387Amiodarone HydrochlorideAmiodarone Hydrochloride

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