PRAZIQUANTEL
These highlights do not include all the information needed to use PRAZIQUANTEL TABLETS safely and effectively. See full prescribing information for PRAZIQUANTEL TABLETS. PRAZIQUANTEL tablets, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
16f2b9c4-a260-4a31-bd52-e5945913246c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRAZIQUANTEL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-231
Application NumberANDA208820
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRAZIQUANTEL
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2019
FDA Product Classification
INGREDIENTS (10)
PRAZIQUANTELActive
Quantity: 600 mg in 1 1
Code: 6490C9U457
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT