HYDROXYCHLOROQUINE SULFATE
These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
Approved
Approval ID
04d8fdbf-8829-4469-a341-8af2a2d91ccc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Laurus Labs Limited
DUNS: 915075687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROXYCHLOROQUINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-971
Application NumberANDA210959
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYCHLOROQUINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2019
FDA Product Classification
INGREDIENTS (9)
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 200 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT