Chloroquine phosphate
CHLOROQUINE PHOSPHATE TABLETS, USP
Approved
Approval ID
4543d87b-6a1a-4e08-9cdd-33b4909c2c21
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Bayshore Pharmaceuticals LLC
DUNS: 968737416
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chloroquine phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-142
Application NumberANDA090610
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chloroquine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLOROQUINE PHOSPHATEActive
Quantity: 250 mg in 1 1
Code: 6E17K3343P
Classification: ACTIB