FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
71610-961
11-digit product format
716100961
Labeler code
71610
Product ID
71610-961_427ac308-f737-d1f0-e063-6294a90ae7a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210577
Marketing category
ANDA
Marketing start
2018-05-17
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-961-30Hydroxychloroquine Sulfate30 in 1 BOTTLETABLET, FILM COATED301
71610-961-53Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED601
71610-961-80Hydroxychloroquine Sulfate180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-961-30EA - Each71610-961c369f6f8-59b3-4c8c-893a-26570407cf7d12025-12-16
71610-961-53EA - Each71610-961d5799668-d085-4f80-ad5f-07dae23f2a4a12025-12-16
71610-961-80EA - Each71610-961ea7f1437-22d7-4721-9789-350adfa2e59912025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN427ac2fc-8f7f-9725-e063-6394a90a381b1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD427ac2fc-8f7f-9725-e063-6394a90a381b1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY427ac2fc-8f7f-9725-e063-6394a90a381b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-961-307161009613030 TABLET, FILM COATED in 1 BOTTLE (71610-961-30) 2025-10-31NoNoCurrent
71610-961-537161009615360 TABLET, FILM COATED in 1 BOTTLE (71610-961-53) 2025-10-31NoNoCurrent
71610-961-8071610096180180 TABLET, FILM COATED in 1 BOTTLE (71610-961-80) 2025-10-31NoNoCurrent