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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0024-1596
Application NumberNDA008316
Product Classification
M
Marketing Category
C73594
G
Generic Name
Primaquine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2019
FDA Product Classification
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