Hydroxychloroquine Sulfate

Product NDC: 42385-927
Requested package NDC: 42385-927-05
11-digit product format: 423850927
Labeler code: 42385
Product ID: 42385-927_04c03db9-7fbe-487e-ae70-551ce45088c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Laurus Labs Limited
Application: ANDA210959
Marketing category: ANDA
Marketing start: 2019-09-05
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	42385-927	42385-927-05	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 · 6 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…`

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
A210959-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2019-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210959-001	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	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2019-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2019-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210959-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2019-01-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210959-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210959-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210959-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210959-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210959-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210959-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210959-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210959-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210959-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210959-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210959-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210959-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210959-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210959-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210959-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210959-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210959-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210959-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210959-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210959-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210959-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210959-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210959-001	AB	1	`c0c555d07b60…`
2019-09-15 20:21 UTC	2019-09	A210959-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210959-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210959-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210959-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210959-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210959-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210959-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210959-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210959-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210959-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210959-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210959-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210959-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210959-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210959-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210959-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-927-01	EA - Each	42385-927	641a6524-5dad-4a3a-9dbf-37a6c62ee16a	1	2020-04-20
42385-927-05	EA - Each	42385-927	0f8f6087-0e56-4816-a7e0-f1078ce2d108	1	2020-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Rising Pharma Holdings, Inc.	6837f2aa-1349-4b45-a0ac-09ec914fd764	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210959 application number: ANDA210959
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Laurus Labs Limited	04d8fdbf-8829-4469-a341-8af2a2d91ccc	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210959 application number: ANDA210959

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42385-927-05	42385092705	500 TABLET, FILM COATED in 1 BOTTLE (42385-927-05)	2019-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate	Laurus Labs Limited \| Laurus Labs Limited (VSP2)	2024-01-05	Human Prescription Drug Label	3