Hydroxychloroquine Sulfate

Product NDC
0781-5994
11-digit product format
007815994
Labeler code
0781
Product ID
0781-5994_e5375cf7-9423-40a4-bd33-ce5812da4a73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA040104
Marketing category
ANDA
Marketing start
1995-11-30
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5994DDiscontinued by firm2026-08-03
excluded packagepackage0781-59940781-5994-01DDiscontinued by firm2026-08-03
excluded packagepackage0781-59940781-5994-05DDiscontinued 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 · 36 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 packagepackage0781-5994-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5994-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5994-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5994-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5994-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5994-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5994-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5994-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5994-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5994-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5994-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5994-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5994-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5994-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5994-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5994-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5994-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5994-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5994-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5994-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5994-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5994-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5994-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5994-01557ba5c1ecfa…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
A040104-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040104-001AB

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 UTC2026-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040104-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30cb3db0bc1861…

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 UTC2026-02A040104-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040104-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040104-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040104-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040104-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040104-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040104-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040104-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040104-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040104-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040104-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040104-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040104-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040104-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040104-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040104-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040104-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040104-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040104-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040104-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040104-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040104-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040104-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040104-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040104-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040104-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040104-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040104-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040104-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040104-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040104-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040104-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040104-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040104-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040104-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040104-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040104-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040104-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040104-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040104-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5994-01EA - Each0781-59949d3e4c55-918f-47e0-9080-58158e73b22512018-04-19
0781-5994-05EA - Each0781-5994179b4fb5-56ff-436c-8558-aed6406e35f912018-04-19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSNa3c2b92b-1bb7-d83c-e053-2a95a90a8fc23
979092hydroxychloroquine sulfate 200 MG Oral TabletSCDa3c2b92b-1bb7-d83c-e053-2a95a90a8fc23
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSYa3c2b92b-1bb7-d83c-e053-2a95a90a8fc23
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN25b29013-29b4-4dd1-b346-632f23a68b572
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD25b29013-29b4-4dd1-b346-632f23a68b572
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY25b29013-29b4-4dd1-b346-632f23a68b572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5994-0100781599401100 TABLET, FILM COATED in 1 BOTTLE (0781-5994-01) 2018-03-070000-00-00NoNoCurrent
0781-5994-0500781599405500 TABLET, FILM COATED in 1 BOTTLE (0781-5994-05) 2018-03-070000-00-00NoNoCurrent