Hydroxychloroquine Sulfate

Product NDC
68084-269
11-digit product format
680840269
Labeler code
68084
Product ID
68084-269_1ea6084a-c32f-e654-e063-6394a90ad851
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-09-03
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
68084-269-01Hydroxychloroquine Sulfate100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10010
68084-269-11Hydroxychloroquine Sulfate1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-269HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240805_a2d7be5a-98ee-4292-8715-46573dbe1c5b.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
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa2d7be5a-98ee-4292-8715-46573dbe1c5b10
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa2d7be5a-98ee-4292-8715-46573dbe1c5b10
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa2d7be5a-98ee-4292-8715-46573dbe1c5b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-269-0168084026901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-269-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-269-11) 100 blister pack2008-09-030000-00-00NoNoCurrent
68084-269-11680840269111 in 1 BLISTER PACKHistorical