Hydroxychloroquine Sulfate

Product NDC
53808-1112
11-digit product format
538081112
Labeler code
53808
Product ID
53808-1112_b2327669-4a74-4e43-904c-d3393fd7952c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA040766
Marketing category
ANDA
Marketing start
2017-08-27
Marketing end
0000-00-00
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC],Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1112-12024-01-30C16284748780-11030e365-2113-111a-e063-dadaa90a10e2Hydroxychloroquine Sulfate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1112-1Hydroxychloroquine Sulfate30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1112HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190130_f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNf0dbb1c2-cdb6-4bf5-9190-3be68da19c9e1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDf0dbb1c2-cdb6-4bf5-9190-3be68da19c9e1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYf0dbb1c2-cdb6-4bf5-9190-3be68da19c9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1112-15380811120130 TABLET, FILM COATED in 1 BLISTER PACK (53808-1112-1) 2017-08-270000-00-00NoNoCurrent