HYDROXYCHLOROQUINE SULFATE

Product NDC
50268-412
11-digit product format
502680412
Labeler code
50268
Product ID
50268-412_47e560c6-bd1f-1264-e063-6394a90a0048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA210441
Marketing category
ANDA
Marketing start
2020-05-15
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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
50268-412-11HYDROXYCHLOROQUINE SULFATE1 in 1 BLISTER PACKTABLET, FILM COATED14
50268-412-15HYDROXYCHLOROQUINE SULFATE50 in 1 BOXTABLET, FILM COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-412HYDROXYCHLOROQUINE SULFATE TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_a5b3455a-e842-7d4b-e053-2995a90adee3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa5b3455a-e842-7d4b-e053-2995a90adee34
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa5b3455a-e842-7d4b-e053-2995a90adee34
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa5b3455a-e842-7d4b-e053-2995a90adee34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-412-11502680412111 in 1 BLISTER PACKHistorical
50268-412-155026804121550 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11) 50 blister pack2020-05-150000-00-00NoNoCurrent