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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-671
Application NumberANDA204476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primaquine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2017
FDA Product Classification
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.