Primaquine Phosphate
PRIMAQUINE PHOSPHATE TABLETS, USP
Approved
Approval ID
1bfbf4ae-81b8-4160-a00d-6322aadd4b59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2021
Manufacturers
FDA
Sanofi-Aventis U.S. LLC
DUNS: 824676584
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 Code0024-1596
Application NumberNDA008316
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 21, 2019
Generic NamePrimaquine Phosphate
INGREDIENTS (12)
PRIMAQUINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: H0982HF78B
Classification: ACTIM
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT