FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
0615-8325
Requested package NDC
0615-8325-39
11-digit product format
006158325
Labeler code
0615
Product ID
0615-8325_97b87080-2b34-4c69-bf25-4d3104f51453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA040133
Marketing category
ANDA
Marketing start
2016-03-30
Marketing end
2022-01-31
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC],Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0615-83250615-8325-39DDiscontinued by firm2026-08-07

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A040133-001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30

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 UTC2026-02A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORAL1995-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040133-001HYDROXYCHLOROQUINE SULFATE200MGTABLET / ORALAB1995-11-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040133-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040133-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040133-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040133-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040133-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040133-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040133-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040133-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040133-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040133-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040133-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040133-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040133-001AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040133-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040133-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040133-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040133-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-8325-392020-04-15C16284748780-1a330e861-b93d-a52c-e053-dbdaa90ad38aHYDROXYCHLOROQUINE SULFATE TABLETS, USP Rx only

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8325-390061583253930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8325-39) 2019-12-022022-01-31NoNoCurrent