Hydroxychloroquine Sulfate

Product NDC
43353-103
11-digit product format
433530103
Labeler code
43353
Product ID
43353-103_5455d995-4fff-448f-8743-6e7bee209371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
Antirheumatic Agent [EPC],Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-103IInactivated by FDA2026-08-03
excluded packagepackage43353-10343353-103-09IInactivated by FDA2026-08-03
excluded packagepackage43353-10343353-103-53IInactivated by FDA2026-08-03
excluded packagepackage43353-10343353-103-60IInactivated by FDA2026-08-03
excluded packagepackage43353-10343353-103-80IInactivated by FDA2026-08-03

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 2 · 105 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 packagepackage43353-103-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-103-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-103-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-103-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-103-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-103-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-103-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-103-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-103-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-103-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-103-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-103-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-103-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-103-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-103-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-103-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-103-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-103-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-103-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-103-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-103-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-103-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-103-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-103-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-103-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-103-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-103-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-103-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-103-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-103-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-103-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-103-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-103-530efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-103-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-103-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-103-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-103-53ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-103-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-103-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-103-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-103-53367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-103-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-103-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-103-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-103-53557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-103-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-103-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-103-80557ba5c1ecfa…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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-103-09EA - Each43353-10383ddb7a7-0ca1-460e-802d-46698069f29c12016-07-19
43353-103-53EA - Each43353-1037278bbe4-31be-4653-b487-75af22deab0e12016-07-19
43353-103-60EA - Each43353-103319637d1-a0e2-4566-b419-789e8099a2c112016-07-19
43353-103-80EA - Each43353-10336055a02-d32a-49f7-8acd-e4bf887f688d12016-07-19