Hydroxychloroquine sulfate

Product NDC
71610-506
11-digit product format
716100506
Labeler code
71610
Product ID
71610-506_2027b984-d53d-41c0-914b-ff66535e0e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-01-03
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
Hydroxychloroquine sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092

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
71610-506-30Hydroxychloroquine sulfate30 in 1 BOTTLETABLET, FILM COATED301
71610-506-53Hydroxychloroquine sulfate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-506-30EA - Each71610-50603e3694f-38e9-4480-8063-f8ac55dbee0a12021-03-02
71610-506-53EA - Each71610-506973704f2-bf1e-45fc-92b9-662cda5402cf12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-506HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210129_90111c26-cd12-4a45-a25f-8d83c83c80de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN90111c26-cd12-4a45-a25f-8d83c83c80de1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD90111c26-cd12-4a45-a25f-8d83c83c80de1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY90111c26-cd12-4a45-a25f-8d83c83c80de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-506-307161005063030 TABLET, FILM COATED in 1 BOTTLE (71610-506-30) 2020-12-220000-00-00NoNoCurrent
71610-506-537161005065360 TABLET, FILM COATED in 1 BOTTLE (71610-506-53) 2020-12-220000-00-00NoNoCurrent