FDA.reportPublic FDA data

Plaquenil

Product NDC
59212-562
11-digit product format
592120562
Labeler code
59212
Product ID
59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA009768
Marketing category
NDA
Marketing start
2013-06-28
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plaquenil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092, 979094

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59212-562-10Plaquenil100 in 1 BOTTLETABLET10015
59212-562-11Plaquenil100 in 1 BOTTLETABLET10015
59212-562-60Plaquenil60 in 1 BOTTLETABLET6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-562-10EA - Each59212-562c4ec417b-969f-4e45-b8fe-b6d720c0f09412016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydroxychloroquine sulfateACTIVE INGREDIENT8Q2869CNVHPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
hydroxychloroquineACTIVE MOIETY4QWG6N8QKHPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Calcium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENTL11K75P92JPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
shellacINACTIVE INGREDIENT46N107B71OPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [CONCORDIA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-562PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [ADVANZ PHARMA (US) CORP.]14Current NDC, Legacy NDC, 3 package rows20250104_34496b43-05a2-45fb-a769-52b12e099341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN34496b43-05a2-45fb-a769-52b12e09934115
979094Plaquenil 200 MG Oral TabletPSN34496b43-05a2-45fb-a769-52b12e09934115
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBD34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY34496b43-05a2-45fb-a769-52b12e09934115
979094Plaquenil 200 MG Oral TabletSY34496b43-05a2-45fb-a769-52b12e09934115
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNeb26c050-fc41-4183-9f8c-86351335fa644
979094Plaquenil 200 MG Oral TabletPSNeb26c050-fc41-4183-9f8c-86351335fa644
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBDeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYeb26c050-fc41-4183-9f8c-86351335fa644
979094Plaquenil 200 MG Oral TabletSYeb26c050-fc41-4183-9f8c-86351335fa644
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa3c311ff-2f87-7780-e053-2995a90aac4e2
979094Plaquenil 200 MG Oral TabletPSNa3c311ff-2f87-7780-e053-2995a90aac4e2
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBDa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa3c311ff-2f87-7780-e053-2995a90aac4e2
979094Plaquenil 200 MG Oral TabletSYa3c311ff-2f87-7780-e053-2995a90aac4e2
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN8aec894d-5711-4079-b167-240713bf04f21
979094Plaquenil 200 MG Oral TabletPSN8aec894d-5711-4079-b167-240713bf04f21
979094hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]SBD8aec894d-5711-4079-b167-240713bf04f21
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD8aec894d-5711-4079-b167-240713bf04f21
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY8aec894d-5711-4079-b167-240713bf04f21
979094Plaquenil 200 MG Oral TabletSY8aec894d-5711-4079-b167-240713bf04f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-562-1059212056210100 TABLET in 1 BOTTLE (59212-562-10) 100 tablet2013-06-280000-00-00NoNoCurrent
59212-562-1159212056211100 TABLET in 1 BOTTLE (59212-562-11) 100 tablet2020-08-100000-00-00NoNoCurrent
59212-562-605921205626060 TABLET in 1 BOTTLE (59212-562-60) 60 tablet2019-01-050000-00-00NoNoCurrent