FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
69238-1544
11-digit product format
692381544
Labeler code
69238
Product ID
69238-1544_d3aae8a7-7df9-4771-8785-7bd6458cdfb1
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
69238-1544-1Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED10017
69238-1544-5Hydroxychloroquine Sulfate500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1544-1EA - Each69238-154422e18427-3a37-408a-95ca-f1147078b3c312018-06-11
69238-1544-5EA - Each69238-1544ba3eaed0-f495-423c-8b8c-86b21ccd315312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1544HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]16Current NDC, Legacy NDC, 2 package rows20250424_7804f5d2-41a6-4523-a277-6967e984e88e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN7804f5d2-41a6-4523-a277-6967e984e88e17
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD7804f5d2-41a6-4523-a277-6967e984e88e17
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY7804f5d2-41a6-4523-a277-6967e984e88e17
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNda435181-0c5a-4188-8d59-51234116b0058
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDda435181-0c5a-4188-8d59-51234116b0058
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYda435181-0c5a-4188-8d59-51234116b0058
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN427ac2fc-8f7f-9725-e063-6394a90a381b1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD427ac2fc-8f7f-9725-e063-6394a90a381b1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY427ac2fc-8f7f-9725-e063-6394a90a381b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1544-169238154401100 TABLET, FILM COATED in 1 BOTTLE (69238-1544-1) 2018-05-170000-00-00NoNoCurrent
69238-1544-569238154405500 TABLET, FILM COATED in 1 BOTTLE (69238-1544-5) 2019-09-170000-00-00NoNoCurrent