Hydroxychloroquine sulfate

Product NDC
71335-0897
11-digit product format
713350897
Labeler code
71335
Product ID
71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0897-1Hydroxychloroquine sulfate100 in 1 BOTTLETABLET, FILM COATED1009
71335-0897-2Hydroxychloroquine sulfate30 in 1 BOTTLETABLET, FILM COATED309
71335-0897-3Hydroxychloroquine sulfate60 in 1 BOTTLETABLET, FILM COATED609
71335-0897-4Hydroxychloroquine sulfate180 in 1 BOTTLETABLET, FILM COATED1809
71335-0897-5Hydroxychloroquine sulfate90 in 1 BOTTLETABLET, FILM COATED909
71335-0897-6Hydroxychloroquine sulfate120 in 1 BOTTLETABLET, FILM COATED1209
71335-0897-7Hydroxychloroquine sulfate10 in 1 BOTTLETABLET, FILM COATED109
71335-0897-8Hydroxychloroquine sulfate14 in 1 BOTTLETABLET, FILM COATED149
71335-0897-9Hydroxychloroquine sulfate20 in 1 BOTTLETABLET, FILM COATED209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0897HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20240724_f618a091-ade1-4c39-ab76-f6218b606e05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNf618a091-ade1-4c39-ab76-f6218b606e059
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDf618a091-ade1-4c39-ab76-f6218b606e059
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYf618a091-ade1-4c39-ab76-f6218b606e059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0897-171335089701100 TABLET, FILM COATED in 1 BOTTLE (71335-0897-1) 2020-07-140000-00-00NoNoCurrent
71335-0897-27133508970230 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2) 2020-03-130000-00-00NoNoCurrent
71335-0897-37133508970360 TABLET, FILM COATED in 1 BOTTLE (71335-0897-3) 2018-07-060000-00-00NoNoCurrent
71335-0897-471335089704180 TABLET, FILM COATED in 1 BOTTLE (71335-0897-4) 2018-07-100000-00-00NoNoCurrent
71335-0897-57133508970590 TABLET, FILM COATED in 1 BOTTLE (71335-0897-5) 2019-02-250000-00-00NoNoCurrent
71335-0897-671335089706120 TABLET, FILM COATED in 1 BOTTLE (71335-0897-6) 2024-07-090000-00-00NoNoCurrent
71335-0897-77133508970710 TABLET, FILM COATED in 1 BOTTLE (71335-0897-7) 2024-07-090000-00-00NoNoCurrent
71335-0897-87133508970814 TABLET, FILM COATED in 1 BOTTLE (71335-0897-8) 2024-07-090000-00-00NoNoCurrent
71335-0897-97133508970920 TABLET, FILM COATED in 1 BOTTLE (71335-0897-9) 2024-07-090000-00-00NoNoCurrent