HYDROXYCHLOROQUINE SULFATE

Product NDC
71335-2813
11-digit product format
713352813
Labeler code
71335
Product ID
71335-2813_48df785b-43a2-49b6-8a5f-0bf9fbffa272
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
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
71335-2813-1HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2813-1EA - Each71335-2813ef3934b7-905c-467f-b5d3-a41fa3e8e49b12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNf95cfc03-5023-44b3-8994-25afac18b7341
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDf95cfc03-5023-44b3-8994-25afac18b7341
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYf95cfc03-5023-44b3-8994-25afac18b7341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2813-171335281301100 TABLET in 1 BOTTLE (71335-2813-1) 100 tablet2025-10-02NoNoCurrent