FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
50090-6280
11-digit product format
500906280
Labeler code
50090
Product ID
50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213342
Marketing category
ANDA
Marketing start
2020-05-12
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
50090-6280-1Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET603
50090-6280-2Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6280-1EA - Each50090-6280b90cd91a-a909-4b02-afa9-e3d5d57cb69d12023-01-09
50090-6280-2EA - Each50090-6280bef06825-6ec7-4b20-9626-322eef48ab2312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6280HYDROXYCHLOROQUINE SULFATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231101_b4dca05a-745f-4c15-b731-1e99176cf44c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNb4dca05a-745f-4c15-b731-1e99176cf44c3
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDb4dca05a-745f-4c15-b731-1e99176cf44c3
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYb4dca05a-745f-4c15-b731-1e99176cf44c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6280-15009062800160 TABLET in 1 BOTTLE (50090-6280-1) 60 tablet2022-12-150000-00-00NoNoCurrent
50090-6280-25009062800290 TABLET in 1 BOTTLE (50090-6280-2) 90 tablet2022-12-150000-00-00NoNoCurrent