Amiodarone Hydrochloride
Amiodarone Hydrochloride Tablets
Approved
Approval ID
57df7b65-7829-4364-894f-ae4c2772c733
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amiodarone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4618
Application NumberANDA079029
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiodarone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2010
FDA Product Classification
INGREDIENTS (7)
AMIODARONE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 976728SY6Z
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT