Hydroxychloroquine Sulfate

Product NDC: 0591-3041
Requested package NDC: 0591-3041-05
11-digit product format: 005913041
Labeler code: 0591
Product ID: 0591-3041_13086805-6932-4286-88b3-baadb6123662
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA040133
Marketing category: ANDA
Marketing start: 2016-03-30
Marketing end: 2022-03-31
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 200 mg/1
Pharmacologic classes: Antimalarial [EPC], Antirheumatic Agent [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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0591-3041	0591-3041-05	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040133-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL			1995-11-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040133-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040133-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040133-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040133-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040133-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040133-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040133-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040133-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040133-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040133-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040133-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040133-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040133-001	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040133-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040133-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040133-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040133-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
476a7bfa-95aa-4caa-a32b-b0e157b2cc83	Product name	1	20220928
79a2ab33-ef76-b1c3-49e7-8533315e153b	Product name	5	20200716

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0591-3041-01	2020-09-30	These 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
0591-3041-05	2020-09-30	These 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
0591-3041-01	2020-09-27	These 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
0591-3041-05	2020-09-27	These 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
0591-3041-01	2020-09-25	These 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
0591-3041-05	2020-09-25	These 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
0591-3041-01	2020-07-22	These 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
0591-3041-05	2020-07-22	These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3041-01	EA - Each	0591-3041	61cff5ca-2be4-4a73-8ac4-a2d5f59d5a8c	1	2016-04-04
0591-3041-05	EA - Each	0591-3041	0407690e-188f-4ce0-a91a-8424068d9d3c	1	2016-04-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE	747-36-4	HYDROXYCHLOROQUINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	9c1abafe-e99f-4c09-aa43-0b60867fdcdb	14
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	9c1abafe-e99f-4c09-aa43-0b60867fdcdb	14
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	9c1abafe-e99f-4c09-aa43-0b60867fdcdb	14
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	1b49a98f-37a8-4b01-8a82-90b947bbc223	3
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	1b49a98f-37a8-4b01-8a82-90b947bbc223	3
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	1b49a98f-37a8-4b01-8a82-90b947bbc223	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3041-05	00591304105	500 TABLET, FILM COATED in 1 BOTTLE (0591-3041-05)	2016-03-30	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	2022-03-17	HUMAN PRESCRIPTION DRUG LABEL	12
Hydroxychloroquine Sulfate Tablets, USP Rx only	A-S Medication Solutions	2021-06-16	HUMAN PRESCRIPTION DRUG LABEL	14
Hydroxychloroquine Sulfate Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2020-12-16	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROXYCHLOROQUINE SULFATE TABLETS, USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2020-04-08	HUMAN PRESCRIPTION DRUG LABEL	4