FDA.reportPublic FDA data

HYDROXYCHLOROQUINE SULFATE

Product NDC
71610-701
11-digit product format
716100701
Labeler code
71610
Product ID
71610-701_7576e78c-5a06-4d83-9f31-bca0a0cfbe87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210441
Marketing category
ANDA
Marketing start
2018-05-01
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
71610-701-53HYDROXYCHLOROQUINE SULFATE60 in 1 BOTTLETABLET602
71610-701-80HYDROXYCHLOROQUINE SULFATE180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-701-53EA - Each71610-7018c76e6b6-b110-4bcd-92be-571850b0edde12023-07-06
71610-701-80EA - Each71610-701ed675b66-970a-47d1-961f-c88266b99eec12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-701HYDROXYCHLOROQUINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 2 package rows20230502_beff29fe-574f-4566-99ac-53ec3b3038a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNbeff29fe-574f-4566-99ac-53ec3b3038a72
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDbeff29fe-574f-4566-99ac-53ec3b3038a72
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYbeff29fe-574f-4566-99ac-53ec3b3038a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-701-537161007015360 TABLET in 1 BOTTLE (71610-701-53) 60 tablet2023-05-01NoNoCurrent
71610-701-8071610070180180 TABLET in 1 BOTTLE (71610-701-80) 180 tablet2023-04-14NoNoCurrent