Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amiodarone Hydrochloride
Product Details
NDC Product Code
60687-437Application Number
ANDA204742Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 19, 2023POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AmiodaroneActive
Code: 976728SY6ZClass: ACTIBQuantity: 200 mg in 1 1