Hydroxychloroquine

Product NDC
62135-752
11-digit product format
621350752
Labeler code
62135
Product ID
62135-752_459cd828-6e8f-c7cf-e063-6394a90a5ab8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210543
Marketing category
ANDA
Marketing start
2018-07-06
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
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
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-752-90Hydroxychloroquine90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-752HYDROXYCHLOROQUINE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240605_7e09aeca-0cec-4a88-9dde-a2098a08b877.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN7e09aeca-0cec-4a88-9dde-a2098a08b8772
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD7e09aeca-0cec-4a88-9dde-a2098a08b8772
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY7e09aeca-0cec-4a88-9dde-a2098a08b8772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-752-906213507529090 TABLET in 1 BOTTLE (62135-752-90) 90 tablet2024-05-28NoNoCurrent