FDA.reportPublic FDA data

Hydroxychloroquine sulfate

Product NDC
55154-2074
11-digit product format
551542074
Labeler code
55154
Product ID
55154-2074_94d0a562-e020-46ba-8558-c407ff60b8e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-08-05
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-2074-02020-04-15C16284748780-1a3303d91-8bae-bd6b-e053-dbdaa90a7920These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
55154-2074-02020-04-15C16284748780-1a3303d91-8bae-bd6b-e053-dbdaa90a7920These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
55154-2074-02020-04-15C16284748780-1a3303d91-8bae-bd6b-e053-dbdaa90a7920These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2074-0Hydroxychloroquine sulfate10 in 1 BAGTABLET, FILM COATED1015
55154-2074-0Hydroxychloroquine sulfate1 in 1 BLISTER PACKTABLET, FILM COATED115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2074HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]14Current NDC, Legacy NDC, 2 package rows20250101_6971241c-8323-456e-91a4-a404a9e100de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN6971241c-8323-456e-91a4-a404a9e100de16
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD6971241c-8323-456e-91a4-a404a9e100de16
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY6971241c-8323-456e-91a4-a404a9e100de16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2074-05515420740010 BLISTER PACK in 1 BAG (55154-2074-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2008-08-050000-00-00NoNoCurrent