Hydroxychloroquine sulfate

Product NDC
65841-633
11-digit product format
658410633
Labeler code
65841
Product ID
65841-633_63d19fd8-9254-4f19-96a7-ec9fd9b0edd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-01-03
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 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 SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-633-01Hydroxychloroquine sulfate100 in 1 BOTTLETABLET, FILM COATED1008
65841-633-05Hydroxychloroquine sulfate500 in 1 BOTTLETABLET, FILM COATED5008
65841-633-30Hydroxychloroquine sulfate10 in 1 BLISTER PACKTABLET, FILM COATED108
65841-633-30Hydroxychloroquine sulfate10 in 1 CARTONTABLET, FILM COATED108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-633HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 4 package rows20241201_1aa44bff-9a62-48b4-a520-98d7d524e3a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN1aa44bff-9a62-48b4-a520-98d7d524e3a98
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD1aa44bff-9a62-48b4-a520-98d7d524e3a98
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY1aa44bff-9a62-48b4-a520-98d7d524e3a98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-633-0165841063301100 TABLET, FILM COATED in 1 BOTTLE (65841-633-01) 2008-01-030000-00-00NoNoCurrent
65841-633-0565841063305500 TABLET, FILM COATED in 1 BOTTLE (65841-633-05) 2008-01-030000-00-00NoNoCurrent
65841-633-306584106333010 BLISTER PACK in 1 CARTON (65841-633-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2008-01-030000-00-00NoNoCurrent