Hydroxychloroquinesulfate
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
Approved
Approval ID
b1b40bfc-6483-45ec-a626-f46c1d761206
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2018
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxychloroquinesulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-120
Application NumberANDA210543
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquinesulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2018
FDA Product Classification
INGREDIENTS (11)
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 200 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT