Hydroxychloroquine Sulfate

Product NDC
50090-4659
Requested package NDC
50090-4659-3
11-digit product format
500904659
Labeler code
50090
Product ID
50090-4659_755581f8-6167-46af-991f-9cb92a16d06c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-465950090-4659-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-465950090-4659-3DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A210577-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210577-001AB

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 UTC2026-02A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210577-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB2018-05-15cb3db0bc1861…

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 UTC2026-02A210577-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210577-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210577-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210577-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210577-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210577-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210577-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210577-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210577-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210577-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210577-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210577-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210577-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210577-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210577-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210577-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210577-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210577-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210577-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210577-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210577-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210577-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210577-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210577-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210577-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210577-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210577-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210577-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210577-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210577-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210577-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210577-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210577-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210577-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210577-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210577-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210577-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210577-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210577-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210577-001AB1cb3db0bc1861…

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 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
87076a61-ce76-475b-ac6d-c33ba617195dAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4659-12024-01-08These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
50090-4659-22024-01-08These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
50090-4659-32024-01-08These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
50090-4659-12023-01-30These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
50090-4659-22023-01-30These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
50090-4659-32023-01-30These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4659-1Hydroxychloroquine Sulfate60 in 1 BOTTLETABLET, FILM COATED6012
50090-4659-2Hydroxychloroquine Sulfate90 in 1 BOTTLETABLET, FILM COATED9012
50090-4659-3Hydroxychloroquine Sulfate12 in 1 BOTTLETABLET, FILM COATED1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4659-1EA - Each50090-465909bbf6cf-74ff-4b72-a93b-bd4583c0d4a412022-12-07
50090-4659-2EA - Each50090-46597a46102e-9d51-4551-8fc9-bc587de09cc212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4659HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20250430_87076a61-ce76-475b-ac6d-c33ba617195d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEBryant Ranch Prepackda435181-0c5a-4188-8d59-51234116b0052026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210577
application number: ANDA210577
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEA-S Medication Solutions87076a61-ce76-475b-ac6d-c33ba617195d2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210577
application number: ANDA210577
ndc (package): 50090-4659-3
ndc (product): 50090-4659
ndc11 (package): 50090465903
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmneal Pharmaceuticals NY LLC7804f5d2-41a6-4523-a277-6967e984e88e2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210577
application number: ANDA210577
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAphena Pharma Solutions - Tennessee, LLC427ac2fc-8f7f-9725-e063-6394a90a381b2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210577
application number: ANDA210577
Hydroxychloroquine SulfateHYDROXYCHLOROQUINE SULFATEAmneal Pharmaceuticals NY LLC6a9e2fc8-bedf-46d4-9973-328dbcb180612024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210577
application number: ANDA210577

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD87076a61-ce76-475b-ac6d-c33ba617195d12
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY87076a61-ce76-475b-ac6d-c33ba617195d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4659-35009046590312 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3) 2020-03-170000-00-00NoNoCurrent