FDA.reportPublic FDA data

Plaquenil

Product NDC
71610-473
11-digit product format
716100473
Labeler code
71610
Product ID
71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plaquenil
Listing expiration
2026-12-31

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
71610-473-04Plaquenil4000 in 1 BOTTLETABLET40004
71610-473-30Plaquenil30 in 1 BOTTLETABLET304
71610-473-53Plaquenil60 in 1 BOTTLETABLET604
71610-473-74Plaquenil500 in 1 BOTTLETABLET5004
71610-473-80Plaquenil180 in 1 BOTTLETABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-473-04EA - Each71610-47356db209e-1224-42c2-ae6a-1a1fee20468d12024-05-16
71610-473-74EA - Each71610-4739d0396ca-3394-48e7-aa3e-3ceec09fd76012024-01-04
71610-473-80EA - Each71610-473fa5a5197-71d9-4166-9044-958c1e5c979d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-473PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 5 package rows20240407_eb26c050-fc41-4183-9f8c-86351335fa64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-473-04716100473044000 TABLET in 1 BOTTLE (71610-473-04) 4000 tablet2024-04-03NoNoCurrent
71610-473-307161004733030 TABLET in 1 BOTTLE (71610-473-30) 30 tablet2020-10-140000-00-00NoNoCurrent
71610-473-537161004735360 TABLET in 1 BOTTLE (71610-473-53) 60 tablet2020-10-140000-00-00NoNoCurrent
71610-473-7471610047374500 TABLET in 1 BOTTLE (71610-473-74) 500 tablet2023-03-24NoNoCurrent
71610-473-8071610047380180 TABLET in 1 BOTTLE (71610-473-80) 180 tablet2020-12-080000-00-00NoNoCurrent