Biltricide
BILTRICIDE TABLETS(praziquantel)
Approved
Approval ID
d6791c7c-749a-4595-937b-32229dd59902
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2017
Manufacturers
FDA
Central Texas Community Health Centers
DUNS: 079674019
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 Code76413-146
Application NumberNDA018714
Product Classification
M
Marketing Category
C73594
G
Generic Name
praziquantel
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2017
FDA Product Classification
INGREDIENTS (9)
PRAZIQUANTELActive
Quantity: 600 mg in 1 1
Code: 6490C9U457
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT