Hydroxychloroquine sulfate

Product NDC
68071-2332
11-digit product format
680712332
Labeler code
68071
Product ID
68071-2332_3c6be558-7aab-97e6-e063-6294a90af84f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040657
Marketing category
ANDA
Marketing start
2019-10-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2332-12025-08-15C16284748780-1f386c649-9984-0266-e053-dadaa90a7c1aHydroxychloroquine sulfate tablets, USP
68071-2332-12023-01-30C16284748780-1f386c649-9984-0266-e053-dadaa90a7c1aHydroxychloroquine sulfate tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2332-1Hydroxychloroquine sulfate100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2332HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 1 package rows20210115_b8e3a352-a1e3-e672-e053-2a95a90a641c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNb8e3a352-a1e3-e672-e053-2a95a90a641c2
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDb8e3a352-a1e3-e672-e053-2a95a90a641c2
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYb8e3a352-a1e3-e672-e053-2a95a90a641c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2332-168071233201100 TABLET, FILM COATED in 1 BOTTLE (68071-2332-1) 2021-01-140000-00-00NoNoCurrent