HYDROXYCHLOROQUINE SULFATE

Product NDC
0904-7046
11-digit product format
009047046
Labeler code
0904
Product ID
0904-7046_a0a69116-862a-4dfa-820f-33e95343edfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYCHLOROQUINE SULFATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210441
Marketing category
ANDA
Marketing start
2018-05-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7046-06HYDROXYCHLOROQUINE SULFATE1 in 1 BLISTER PACKTABLET, FILM COATED17
0904-7046-06HYDROXYCHLOROQUINE SULFATE50 in 1 CARTONTABLET, FILM COATED507
0904-7046-61HYDROXYCHLOROQUINE SULFATE1 in 1 BLISTER PACKTABLET, FILM COATED17
0904-7046-61HYDROXYCHLOROQUINE SULFATE100 in 1 CARTONTABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7046HYDROXYCHLOROQUINE SULFATE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 4 package rows20250110_ebe00e35-ed3d-40f4-9a93-a37b0da01ddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYebe00e35-ed3d-40f4-9a93-a37b0da01ddb7
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNe5fe2ece-40a1-49eb-818f-62ff3c3bb1995
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDe5fe2ece-40a1-49eb-818f-62ff3c3bb1995
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYe5fe2ece-40a1-49eb-818f-62ff3c3bb1995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7046-060090470460650 BLISTER PACK in 1 CARTON (0904-7046-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2018-05-010000-00-00NoNoCurrent
0904-7046-6100904704661100 BLISTER PACK in 1 CARTON (0904-7046-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2018-05-010000-00-00NoNoCurrent