Plaquenil
These highlights do not include all the information needed to use PLAQUENIL® safely and effectively. See full prescribing information for PLAQUENIL. PLAQUENIL (hydroxychloroquine sulfate) tablets, for oral use Initial U.S. Approval: 1955
Approved
Approval ID
34496b43-05a2-45fb-a769-52b12e099341
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
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 Code59212-562
Application NumberNDA009768
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydroxychloroquine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2021
FDA Product Classification
INGREDIENTS (10)
hydroxychloroquine sulfateActive
Quantity: 200 mg in 1 1
Code: 8Q2869CNVH
Classification: ACTIB
Calcium Phosphate, Dibasic, AnhydrousInactive
Code: L11K75P92J
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT