Hydroxychloroquine Sulfate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1955
Approved
Approval ID
84b00366-96ef-41e1-bac6-5d24acdb9e1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Accord Healthcare, Inc.,
DUNS: 604222237
Products 4
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 Code16729-563
Application NumberANDA213342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 400 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Hydroxychloroquine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-485
Application NumberANDA213342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (9)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 200 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Hydroxychloroquine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-561
Application NumberANDA213342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 100 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
Hydroxychloroquine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-562
Application NumberANDA213342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxychloroquine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYCHLOROQUINE SULFATEActive
Quantity: 300 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB