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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

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