Primaquine Phosphate
PRIMAQUINE PHOSPHATE TABLETS, USP
Approved
Approval ID
5c920cdf-5c1e-43f7-a275-c72040005715
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2017
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Primaquine Phosphate
PRODUCT DETAILS
NDC Product Code33261-671
Application NumberANDA204476
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 8, 2017
Generic NamePrimaquine Phosphate
INGREDIENTS (11)
PRIMAQUINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: H0982HF78B
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 7/19/2017
WARNING
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PRIMAQUINE PHOSPHATE.
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 7/19/2017
INDICATIONS AND USAGE
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.