FDA.reportPublic FDA data

HYDROXYCHLOROQUINE SULFATE

Product NDC
71335-3113
11-digit product format
713353113
Labeler code
71335
Product ID
71335-3113_b620fa12-9bce-484e-b2f1-02bb6d8315be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxychloroquine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040150
Marketing category
ANDA
Marketing start
2025-05-08
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
HYDROXYCHLOROQUINE SULFATE
Listing expiration
2027-12-31

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
71335-3113-1HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLETABLET1001
71335-3113-2HYDROXYCHLOROQUINE SULFATE30 in 1 BOTTLETABLET301
71335-3113-3HYDROXYCHLOROQUINE SULFATE60 in 1 BOTTLETABLET601
71335-3113-4HYDROXYCHLOROQUINE SULFATE180 in 1 BOTTLETABLET1801
71335-3113-5HYDROXYCHLOROQUINE SULFATE90 in 1 BOTTLETABLET901
71335-3113-6HYDROXYCHLOROQUINE SULFATE120 in 1 BOTTLETABLET1201
71335-3113-7HYDROXYCHLOROQUINE SULFATE10 in 1 BOTTLETABLET101
71335-3113-8HYDROXYCHLOROQUINE SULFATE14 in 1 BOTTLETABLET141
71335-3113-9HYDROXYCHLOROQUINE SULFATE20 in 1 BOTTLETABLET201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN1a39c45e-dc14-4441-9b02-7329647bc5a41
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD1a39c45e-dc14-4441-9b02-7329647bc5a41
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY1a39c45e-dc14-4441-9b02-7329647bc5a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3113-171335311301100 TABLET in 1 BOTTLE (71335-3113-1) 100 tablet2026-03-30NoNoHistorical
71335-3113-27133531130230 TABLET in 1 BOTTLE (71335-3113-2) 30 tablet2026-03-30NoNoHistorical
71335-3113-37133531130360 TABLET in 1 BOTTLE (71335-3113-3) 60 tablet2026-03-30NoNoHistorical
71335-3113-471335311304180 TABLET in 1 BOTTLE (71335-3113-4) 180 tablet2026-03-30NoNoHistorical
71335-3113-57133531130590 TABLET in 1 BOTTLE (71335-3113-5) 90 tablet2026-03-30NoNoHistorical
71335-3113-671335311306120 TABLET in 1 BOTTLE (71335-3113-6) 120 tablet2026-03-30NoNoHistorical
71335-3113-77133531130710 TABLET in 1 BOTTLE (71335-3113-7) 10 tablet2026-03-30NoNoHistorical
71335-3113-87133531130814 TABLET in 1 BOTTLE (71335-3113-8) 14 tablet2026-03-30NoNoHistorical
71335-3113-97133531130920 TABLET in 1 BOTTLE (71335-3113-9) 20 tablet2026-03-30NoNoHistorical