FDA.reportPublic FDA data

Hydroxychloroquine sulfate

Product NDC
16714-110
11-digit product format
167140110
Labeler code
16714
Product ID
16714-110_09ec5070-4e0b-4cf5-b3f1-67c0152b84a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northstar Rx LLC.
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-110-01Hydroxychloroquine sulfate100 in 1 BOTTLETABLET, FILM COATED1006
16714-110-02Hydroxychloroquine sulfate500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-110-01EA - Each16714-1101b48e5e1-4177-4f97-8157-c90799becab112020-02-13
16714-110-02EA - Each16714-110fe80e29d-21a6-435e-84bc-fef24230876712022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-110HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [NORTHSTAR RX LLC.]6Current NDC, Legacy NDC, 2 package rows20240217_29ba0172-7ca3-4122-af1b-f0da522318cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN6a06ad3d-2d6c-4e51-93f5-8f782b86975b8
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD6a06ad3d-2d6c-4e51-93f5-8f782b86975b8
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY6a06ad3d-2d6c-4e51-93f5-8f782b86975b8
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN29ba0172-7ca3-4122-af1b-f0da522318cb6
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD29ba0172-7ca3-4122-af1b-f0da522318cb6
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY29ba0172-7ca3-4122-af1b-f0da522318cb6
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN1a1fb21d-a01c-4d50-8764-cdd6c20d95693
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD1a1fb21d-a01c-4d50-8764-cdd6c20d95693
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY1a1fb21d-a01c-4d50-8764-cdd6c20d95693
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
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN4902343c-7d1b-ba70-e063-6294a90a36801
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN19816051-c25e-44b5-a127-e846dbd0a8d81
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD4902343c-7d1b-ba70-e063-6294a90a36801
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD19816051-c25e-44b5-a127-e846dbd0a8d81
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY4902343c-7d1b-ba70-e063-6294a90a36801
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY19816051-c25e-44b5-a127-e846dbd0a8d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-110-0116714011001100 TABLET, FILM COATED in 1 BOTTLE (16714-110-01) 2019-10-010000-00-00NoNoCurrent
16714-110-0216714011002500 TABLET, FILM COATED in 1 BOTTLE (16714-110-02) 2021-12-030000-00-00NoNoCurrent