Hydroxychloroquine Sulfate

Product NDC
71610-047
11-digit product format
716100047
Labeler code
71610
Product ID
71610-047_46b63bfa-ce1b-430a-be8b-c751574608e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040104
Marketing category
ANDA
Marketing start
1995-11-30
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-047-602023-01-30C16284748780-1f386c64a-3d34-0266-e053-dadaa90a7c1aHydroxychloroquine Sulfate Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-047-60Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-047-60EA - Each71610-047e8841d7a-ec22-430d-a2e7-60860226105712018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-047HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20191227_25b29013-29b4-4dd1-b346-632f23a68b57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN25b29013-29b4-4dd1-b346-632f23a68b572
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD25b29013-29b4-4dd1-b346-632f23a68b572
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY25b29013-29b4-4dd1-b346-632f23a68b572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-047-607161000476090 TABLET, FILM COATED in 1 BOTTLE (71610-047-60) 2018-04-060000-00-00NoNoCurrent