Plaquenil

Product NDC
71205-448
11-digit product format
712050448
Labeler code
71205
Product ID
71205-448_8aec894d-5711-4079-b167-240713bf04f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-448-12Plaquenil12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-448-12EA - Each71205-448a06e4cc0-3a7b-483c-a318-92c58468871012020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-448PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 1 package rows20200411_8aec894d-5711-4079-b167-240713bf04f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-448-127120504481212 TABLET in 1 BOTTLE (71205-448-12) 12 tablet2020-04-080000-00-00NoNoCurrent