Hydroxychloroquine sulfate

Product NDC
68071-4648
11-digit product format
680714648
Labeler code
68071
Product ID
68071-4648_d6071791-53cd-6fad-e053-2a95a90a8fc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-01-03
Marketing end
0000-00-00
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-4648DDiscontinued by firm2026-08-03
excluded packagepackage68071-464868071-4648-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4648-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4648-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4648-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4648-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4648-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4648-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4648-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4648-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-4648-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-4648-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-4648-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4648-1557ba5c1ecfa…9c80585c8c6e…

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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4648-168071464801100 TABLET, FILM COATED in 1 BOTTLE (68071-4648-1) 2018-12-040000-00-00NoNoCurrent