FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
50090-2508
11-digit product format
500902508
Labeler code
50090
Product ID
50090-2508_e05872d7-2b88-4252-9a27-22c7a0f347a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040133
Marketing category
ANDA
Marketing start
2016-03-30
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2508-02023-01-30C16284748780-1f386c649-f449-0266-e053-dadaa90a7c1aHydroxychloroquine Sulfate Tablets, USP Rx only
50090-2508-12023-01-30C16284748780-1f386c649-f449-0266-e053-dadaa90a7c1aHydroxychloroquine Sulfate Tablets, USP Rx only
50090-2508-22023-01-30C16284748780-1f386c649-f449-0266-e053-dadaa90a7c1aHydroxychloroquine Sulfate Tablets, USP Rx only
50090-2508-32023-01-30C16284748780-1f386c649-f449-0266-e053-dadaa90a7c1aHydroxychloroquine Sulfate Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2508-0Hydroxychloroquine Sulfate30 in 1 BOTTLETABLET, FILM COATED3014
50090-2508-1Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED6014
50090-2508-2Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED9014
50090-2508-3Hydroxychloroquine Sulfate12 in 1 BOTTLETABLET, FILM COATED1214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2508-1EA - Each50090-2508977d391e-90ee-4b15-a00b-4804c737bc1c12019-03-12
50090-2508-2EA - Each50090-250857fb3898-09f1-4500-b7d5-7d0c2a25fa3c12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2508HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Legacy NDC, 4 package rows20210617_9c1abafe-e99f-4c09-aa43-0b60867fdcdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN9c1abafe-e99f-4c09-aa43-0b60867fdcdb14
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD9c1abafe-e99f-4c09-aa43-0b60867fdcdb14
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY9c1abafe-e99f-4c09-aa43-0b60867fdcdb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2508-05009025080030 TABLET, FILM COATED in 1 BOTTLE (50090-2508-0) 2019-10-090000-00-00NoNoCurrent
50090-2508-15009025080160 TABLET, FILM COATED in 1 BOTTLE (50090-2508-1) 2016-10-140000-00-00NoNoCurrent
50090-2508-25009025080290 TABLET, FILM COATED in 1 BOTTLE (50090-2508-2) 2018-05-110000-00-00NoNoCurrent
50090-2508-35009025080312 TABLET, FILM COATED in 1 BOTTLE (50090-2508-3) 2020-03-170000-00-00NoNoCurrent