"0615-8538-39" National Drug Code (NDC)

Amiodarone Hydrochloride 30 TABLET in 1 BLISTER PACK (0615-8538-39)
(NCS HealthCare of KY, LLC dba Vangard Labs)

NDC Code0615-8538-39
Package Description30 TABLET in 1 BLISTER PACK (0615-8538-39)
Product NDC0615-8538
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20240315
Marketing Category NameANDA
Application NumberANDA075389
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
Substance NameAMIODARONE HYDROCHLORIDE
Strength100
Strength Unitmg/1
Pharmacy ClassesAntiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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