NDC 0615-8258

Amiodarone Hydrochloride

Amiodarone Hydrochloride

Amiodarone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Amiodarone Hydrochloride.

Product ID0615-8258_1bdd90a5-9f6b-45e5-8d77-c1d26dcc3802
NDC0615-8258
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone Hydrochloride
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA204742
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesCytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0615-8258-05

15 TABLET in 1 BLISTER PACK (0615-8258-05)
Marketing Start Date2019-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8258-39 [00615825839]

Amiodarone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA204742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-05

NDC 0615-8258-05 [00615825805]

Amiodarone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA204742
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-05

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:d42293e9-07fa-41b4-a08b-2e388f5b1e13
Manufacturer
UNII

Pharmacological Class

  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Antiarrhythmic [EPC]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 1A2 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Antiarrhythmic [EPC]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 1A2 Inhibitors [MoA]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.