FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
16729-485
11-digit product format
167290485
Labeler code
16729
Product ID
16729-485_4e68b971-e226-d3ff-e063-6294a90ae772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare, Inc.,
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxychloroquine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092, 1119312, 2569281, 2569283

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
16729-485-01Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET10010
16729-485-16Hydroxychloroquine Sulfate500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-485-01EA - Each16729-485e87922f0-90d5-4e74-9abb-9fcf52406f9812020-05-08
16729-485-16EA - Each16729-4855bb96aa9-313c-4377-9737-0669e8eedf9512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-485HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,]8Current NDC, Legacy NDC, 2 package rows20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2569281hydroxychloroquine sulfate 100 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569283hydroxychloroquine sulfate 300 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
1119312hydroxychloroquine sulfate 400 MG Oral TabletPSN84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569281hydroxychloroquine sulfate 100 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
2569283hydroxychloroquine sulfate 300 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
1119312hydroxychloroquine sulfate 400 MG Oral TabletSCD84b00366-96ef-41e1-bac6-5d24acdb9e1d10
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY84b00366-96ef-41e1-bac6-5d24acdb9e1d10
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
16729-485-0116729048501100 TABLET in 1 BOTTLE (16729-485-01) 100 tablet2021-01-260000-00-00NoNoCurrent
16729-485-1616729048516500 TABLET in 1 BOTTLE (16729-485-16) 500 tablet2020-05-120000-00-00NoNoCurrent