Hydroxychloroquine Sulfate

Product NDC
60219-1544
11-digit product format
602191544
Labeler code
60219
Product ID
60219-1544_9ed00eb1-8c8a-4ef0-af47-ab11bc98a9d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210577
Marketing category
ANDA
Marketing start
2018-05-17
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1544-1Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1544HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, Legacy NDC, 1 package rows20240621_6a9e2fc8-bedf-46d4-9973-328dbcb18061.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN6a9e2fc8-bedf-46d4-9973-328dbcb180615
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD6a9e2fc8-bedf-46d4-9973-328dbcb180615
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY6a9e2fc8-bedf-46d4-9973-328dbcb180615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60219-1544-160219154401100 TABLET, FILM COATED in 1 BOTTLE (60219-1544-1) 2018-05-170000-00-00NoNoCurrent