FDA.reportPublic FDA data

HYDROXYCHLOROQUINE SULFATE

Product NDC
82619-131
11-digit product format
826190131
Labeler code
82619
Product ID
82619-131_40b93dff-c062-433c-e063-6294a90a6b67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxychloroquine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
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
82619-131-01HYDROXYCHLOROQUINE SULFATE100 in 1 BOTTLETABLET1003
82619-131-02HYDROXYCHLOROQUINE SULFATE500 in 1 BOTTLETABLET5003
82619-131-03HYDROXYCHLOROQUINE SULFATE1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-131HYDROXYCHLOROQUINE SULFATE TABLET [CREEKWOOD PHARMACEUTICALS LLC]1Current NDC, 3 package rows20250508_04139607-f7c0-4fe1-a210-ffa5af347d56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN517ee47b-6abf-43cb-a4ca-c2e7827461a8102
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD517ee47b-6abf-43cb-a4ca-c2e7827461a8102
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY517ee47b-6abf-43cb-a4ca-c2e7827461a8102
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN04139607-f7c0-4fe1-a210-ffa5af347d563
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD04139607-f7c0-4fe1-a210-ffa5af347d563
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY04139607-f7c0-4fe1-a210-ffa5af347d563
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN1a39c45e-dc14-4441-9b02-7329647bc5a41
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN84957919-ca14-4c3d-b4fe-452ff330dd7a1
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNf95cfc03-5023-44b3-8994-25afac18b7341
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD1a39c45e-dc14-4441-9b02-7329647bc5a41
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD84957919-ca14-4c3d-b4fe-452ff330dd7a1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDf95cfc03-5023-44b3-8994-25afac18b7341
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY1a39c45e-dc14-4441-9b02-7329647bc5a41
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY84957919-ca14-4c3d-b4fe-452ff330dd7a1
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
82619-131-0182619013101100 TABLET in 1 BOTTLE (82619-131-01) 100 tablet2025-05-08NoNoCurrent
82619-131-0282619013102500 TABLET in 1 BOTTLE (82619-131-02) 500 tablet2025-05-08NoNoCurrent
82619-131-03826190131031000 TABLET in 1 BOTTLE (82619-131-03) 1000 tablet2025-05-08NoNoCurrent