HYDROXYCHLOROQUINE SULFATE

Product NDC
71335-2814
11-digit product format
713352814
Labeler code
71335
Product ID
71335-2814_f7e73d47-e8f9-4699-8713-b9194a8ffb1c
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
71335-2814-1HYDROXYCHLOROQUINE SULFATE500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2814-1EA - Each71335-281497192181-6d0c-4adb-8db6-295400aeefba12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN84957919-ca14-4c3d-b4fe-452ff330dd7a1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD84957919-ca14-4c3d-b4fe-452ff330dd7a1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY84957919-ca14-4c3d-b4fe-452ff330dd7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2814-171335281401500 TABLET in 1 BOTTLE (71335-2814-1) 500 tablet2025-10-02NoNoHistorical