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. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955
Approved
Approval ID
f2002851-852f-4ee8-e053-2a95a90a242d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2912
Application NumberANDA040657
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (8)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 200 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT