Hydroxychloroquine Sulfate

Product NDC
0093-2401
11-digit product format
000932401
Labeler code
0093
Product ID
0093-2401_0c6c28a5-e86f-4643-bb22-f7eb5b1f440d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040081
Marketing category
ANDA
Marketing start
2020-10-08
Marketing end
2026-11-30
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxychloroquine Sulfate

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
0093-2401-01Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2401HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]5Current NDC, Legacy NDC, 1 package rows20240229_5f3e49b2-dc11-40a9-b366-c88e36a471e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNcf4b1912-9806-4ef3-bf17-152a96d75bbc104
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDcf4b1912-9806-4ef3-bf17-152a96d75bbc104
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYcf4b1912-9806-4ef3-bf17-152a96d75bbc104
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN5f3e49b2-dc11-40a9-b366-c88e36a471e56
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD5f3e49b2-dc11-40a9-b366-c88e36a471e56
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY5f3e49b2-dc11-40a9-b366-c88e36a471e56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-2401-0100093240101100 TABLET, FILM COATED in 1 BOTTLE (0093-2401-01) 2020-10-082026-11-30NoNoCurrent