MedPath

Primaquine Phosphate

PRIMAQUINE PHOSPHATE TABLETS, USP

Approved
Approval ID

3f16166d-678e-51aa-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 19, 2023

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

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 Code43063-721
Application NumberANDA204476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primaquine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2023
FDA Product Classification

INGREDIENTS (11)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PRIMAQUINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: H0982HF78B
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 10/7/2015

HOW SUPPLIED

Primaquine Phosphate USP Tablets are solid oral formulation round tablet debossed "BY4" available in 26.3 mg.

Available in bottles of 14 (NDC 43063-721-14), bottles of 28 (NDC 43063-721-28)

Store at controlled room temperature: 25°C (77°F); excursions are permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP/NF.

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