FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
71335-3079
11-digit product format
713353079
Labeler code
71335
Product ID
71335-3079_ba997192-35d2-47c0-9d80-10500935bcad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040766
Marketing category
ANDA
Marketing start
2024-06-03
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

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
71335-3079-1Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED1001
71335-3079-2Hydroxychloroquine Sulfate30 in 1 BOTTLETABLET, FILM COATED301
71335-3079-3Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED601
71335-3079-4Hydroxychloroquine Sulfate180 in 1 BOTTLETABLET, FILM COATED1801
71335-3079-5Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED901
71335-3079-6Hydroxychloroquine Sulfate120 in 1 BOTTLETABLET, FILM COATED1201
71335-3079-7Hydroxychloroquine Sulfate10 in 1 BOTTLETABLET, FILM COATED101
71335-3079-8Hydroxychloroquine Sulfate14 in 1 BOTTLETABLET, FILM COATED141
71335-3079-9Hydroxychloroquine Sulfate20 in 1 BOTTLETABLET, FILM COATED201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3079-171335307901100 TABLET, FILM COATED in 1 BOTTLE (71335-3079-1) 2026-02-13NoNoHistorical
71335-3079-27133530790230 TABLET, FILM COATED in 1 BOTTLE (71335-3079-2) 2026-02-13NoNoHistorical
71335-3079-37133530790360 TABLET, FILM COATED in 1 BOTTLE (71335-3079-3) 2026-02-13NoNoHistorical
71335-3079-471335307904180 TABLET, FILM COATED in 1 BOTTLE (71335-3079-4) 2026-02-13NoNoHistorical
71335-3079-57133530790590 TABLET, FILM COATED in 1 BOTTLE (71335-3079-5) 2026-02-13NoNoHistorical
71335-3079-671335307906120 TABLET, FILM COATED in 1 BOTTLE (71335-3079-6) 2026-02-13NoNoHistorical
71335-3079-77133530790710 TABLET, FILM COATED in 1 BOTTLE (71335-3079-7) 2026-02-13NoNoHistorical
71335-3079-87133530790814 TABLET, FILM COATED in 1 BOTTLE (71335-3079-8) 2026-02-13NoNoHistorical
71335-3079-97133530790920 TABLET, FILM COATED in 1 BOTTLE (71335-3079-9) 2026-02-13NoNoHistorical