Hydroxychloroquine sulfate

Product NDC
71335-0897
Requested package NDC
71335-0897-2
11-digit product format
713350897
Labeler code
71335
Product ID
71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040657
Marketing category
ANDA
Marketing start
2008-01-03
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
f618a091-ade1-4c39-ab76-f6218b606e05Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0897-1Hydroxychloroquine sulfate100 in 1 BOTTLETABLET, FILM COATED1009
71335-0897-2Hydroxychloroquine sulfate30 in 1 BOTTLETABLET, FILM COATED309
71335-0897-3Hydroxychloroquine sulfate60 in 1 BOTTLETABLET, FILM COATED609
71335-0897-4Hydroxychloroquine sulfate180 in 1 BOTTLETABLET, FILM COATED1809
71335-0897-5Hydroxychloroquine sulfate90 in 1 BOTTLETABLET, FILM COATED909
71335-0897-6Hydroxychloroquine sulfate120 in 1 BOTTLETABLET, FILM COATED1209
71335-0897-7Hydroxychloroquine sulfate10 in 1 BOTTLETABLET, FILM COATED109
71335-0897-8Hydroxychloroquine sulfate14 in 1 BOTTLETABLET, FILM COATED149
71335-0897-9Hydroxychloroquine sulfate20 in 1 BOTTLETABLET, FILM COATED209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0897HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20240724_f618a091-ade1-4c39-ab76-f6218b606e05.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
ndc (package): 71335-0897-2
ndc (product): 71335-0897
ndc11 (package): 71335089702
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNf618a091-ade1-4c39-ab76-f6218b606e059
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDf618a091-ade1-4c39-ab76-f6218b606e059
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYf618a091-ade1-4c39-ab76-f6218b606e059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0897-27133508970230 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2) 2020-03-130000-00-00NoNoCurrent