Pacerone
PACERONE (Amiodarone HCl) Tablets, 100 mg and 200 mg
Approved
Approval ID
2eceb4d5-0c47-49c3-8263-46f689388efe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code67544-570
Application NumberANDA075135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiodarone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2014
FDA Product Classification
INGREDIENTS (9)
Amiodarone HydrochlorideActive
Quantity: 200 mg in 1 1
Code: 976728SY6Z
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT