Hydroxychloroquine Sulfate

Product NDC: 53808-1112
Requested package NDC: 53808-1112-1
11-digit product format: 538081112
Labeler code: 53808
Product ID: 53808-1112_b2327669-4a74-4e43-904c-d3393fd7952c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: ANDA040766
Marketing category: ANDA
Marketing start: 2017-08-27
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53808-1112	53808-1112-1	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A040766-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2007-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040766-001	AB

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	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040766-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040766-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83	Product name	1	20220928
79a2ab33-ef76-b1c3-49e7-8533315e153b	Product name	5	20200716
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1112-1	2024-01-30	C162847	48780-1	1030e365-2113-111a-e063-dadaa90a10e2	Hydroxychloroquine Sulfate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1112-1	Hydroxychloroquine Sulfate	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1112	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20190130_f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	37413f6b-fb68-4e0c-8bcc-c5b76e956dfc	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Coupler LLC	2eeaf562-95f9-bcef-e063-6394a90a1c19	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Ipca Laboratories Limited	9dfa0ff8-e8cf-47f9-847a-b86f23dc39df	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766

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	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53808-1112-1	53808111201	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1112-1)	2017-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate Tablets, USP	DOH CENTRAL PHARMACY	2019-01-29	HUMAN PRESCRIPTION DRUG LABEL	1