Hydroxychloroquine sulfate

Product NDC
82009-045
11-digit product format
820090045
Labeler code
82009
Product ID
82009-045_ddd9bc99-2f96-4baf-82a4-6fb27a3bdc07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA040657
Marketing category
ANDA
Marketing start
2022-09-30
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
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-045-05Hydroxychloroquine sulfate500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-045-05EA - Each82009-04572ce7261-b85b-41a8-8e6a-27178e98bfc612022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-045HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20240217_81e68f23-b1bf-4561-8f02-a472631acfaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN81e68f23-b1bf-4561-8f02-a472631acfaf3
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD81e68f23-b1bf-4561-8f02-a472631acfaf3
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY81e68f23-b1bf-4561-8f02-a472631acfaf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-045-0582009004505500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05) 2022-09-300000-00-00NoNoCurrent