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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040657-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040657-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040657-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2007-09-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040657-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040657-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040657-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040657-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040657-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040657-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040657-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040657-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040657-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040657-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040657-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040657-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040657-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040657-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040657-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040657-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040657-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040657-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040657-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040657-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040657-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040657-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040657-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040657-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040657-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040657-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040657-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040657-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040657-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040657-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040657-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040657-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040657-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040657-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040657-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040657-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040657-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040657-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040657-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040657-001AB1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8Q2869CNVHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979092Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
29ba0172-7ca3-4122-af1b-f0da522318cbAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATECardinal Health 107, LLC6971241c-8323-456e-91a4-a404a9e100de2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEPreferred Pharmaceuticals, Inc.d6c8ee2e-116e-4167-8d1a-bd570a1ce6722026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals, Inc.4902343c-7d1b-ba70-e063-6294a90a36802026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEZydus Lifesciences Limited1aa44bff-9a62-48b4-a520-98d7d524e3a92025-10-04Exact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENuCare Pharmaceuticals,Inc.b8e3a352-a1e3-e672-e053-2a95a90a641c2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions6a06ad3d-2d6c-4e51-93f5-8f782b86975b2025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions3817387f-2fc8-4f39-8096-3b48fff57ab02024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions53553ef5-5f44-4d39-ae8c-c9a632cc84162024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEAsclemed USA, Inc.19816051-c25e-44b5-a127-e846dbd0a8d82024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmerican Health Packaginga2d7be5a-98ee-4292-8715-46573dbe1c5b2024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackf618a091-ade1-4c39-ab76-f6218b606e052024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENCS HealthCare of KY, LLC dba Vangard Labs83cb17e9-ce57-48aa-b92c-ac0dee92d5bc2024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions1a1fb21d-a01c-4d50-8764-cdd6c20d95692024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATENorthstar Rx LLC.29ba0172-7ca3-4122-af1b-f0da522318cb2023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
ndc (product): 16714-110
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEQuallent Pharmaceuticals Health LLC81e68f23-b1bf-4561-8f02-a472631acfaf2023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEZydus Pharmaceuticals USA Inc.805a1acd-2e0d-48f1-af6b-0e5d8e06c2282023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657
Hydroxychloroquine sulfateHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLC90111c26-cd12-4a45-a25f-8d83c83c80de2020-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040657
application number: ANDA040657

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