Hydroxychloroquine sulfate

Product NDC
68788-7747
11-digit product format
687887747
Labeler code
68788
Product ID
68788-7747_46f2a37e-58bc-4b9e-b9d7-c10e00e34866
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040657
Marketing category
ANDA
Marketing start
2020-07-01
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
68788-7747-2Hydroxychloroquine sulfate20 in 1 BOTTLETABLET, FILM COATED207
68788-7747-3Hydroxychloroquine sulfate30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7747HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240524_d6c8ee2e-116e-4167-8d1a-bd570a1ce672.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNd6c8ee2e-116e-4167-8d1a-bd570a1ce6727
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDd6c8ee2e-116e-4167-8d1a-bd570a1ce6727
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYd6c8ee2e-116e-4167-8d1a-bd570a1ce6727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7747-26878877470220 TABLET, FILM COATED in 1 BOTTLE (68788-7747-2) 2020-07-010000-00-00NoNoCurrent
68788-7747-36878877470330 TABLET, FILM COATED in 1 BOTTLE (68788-7747-3) 2020-07-010000-00-00NoNoCurrent