Hydroxychloroquine sulfate

Product NDC
0615-8459
11-digit product format
006158459
Labeler code
0615
Product ID
0615-8459_da9a93a0-69ed-4967-b7c5-94d742615fae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
0615-8459-39Hydroxychloroquine sulfate30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8459HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 1 package rows20240625_83cb17e9-ce57-48aa-b92c-ac0dee92d5bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8459-390061584593930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8459-39) 2023-04-13NoNoCurrent