HYDROXYCHLOROQUINE SULFATE

Product NDC
63629-4465
11-digit product format
636294465
Labeler code
63629
Product ID
63629-4465_55eb56c0-c585-4373-a3a4-9276aaeae6d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210441
Marketing category
ANDA
Marketing start
2022-10-24
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
300 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 SULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui2569283

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
63629-4465-1HYDROXYCHLOROQUINE SULFATE30 in 1 BOTTLETABLET301
63629-4465-2HYDROXYCHLOROQUINE SULFATE14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4465HYDROXYCHLOROQUINE SULFATE TABLET [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20240817_2c109188-d28b-4c65-8b52-819bd8547f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569283hydroxychloroquine sulfate 300 MG Oral TabletPSN2c109188-d28b-4c65-8b52-819bd8547f2e1
2569283hydroxychloroquine sulfate 300 MG Oral TabletSCD2c109188-d28b-4c65-8b52-819bd8547f2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4465-16362944650130 TABLET in 1 BOTTLE (63629-4465-1) 30 tablet2024-08-16NoNoCurrent
63629-4465-26362944650214 TABLET in 1 BOTTLE (63629-4465-2) 14 tablet2024-08-16NoNoCurrent