Hydroxychloroquine sulfate

Product NDC: 68071-2912
Requested package NDC: 68071-2912-9
11-digit product format: 680712912
Labeler code: 68071
Product ID: 68071-2912_f20028aa-cf0b-a30a-e053-2a95a90a8c98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040657
Marketing category: ANDA
Marketing start: 2008-01-03
Marketing end: 0000-00-00
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 200 mg/1
Pharmacologic classes: Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	68071-2912	68071-2912-9	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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A040657-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2007-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040657-001	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	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040657-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-09-21	`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	A040657-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040657-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040657-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040657-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040657-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040657-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040657-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040657-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040657-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040657-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040657-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040657-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040657-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040657-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040657-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040657-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040657-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040657-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040657-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040657-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040657-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040657-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040657-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040657-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040657-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040657-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040657-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040657-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040657-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040657-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040657-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040657-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040657-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040657-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040657-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040657-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040657-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040657-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040657-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040657-001	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2912-2	2025-01-30	C162847	48780-1	2cef2736-912a-d83d-e063-dadaa90ab31f	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. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955
68071-2912-3	2025-01-30	C162847	48780-1	2cef2736-912a-d83d-e063-dadaa90ab31f	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. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955
68071-2912-9	2025-01-30	C162847	48780-1	2cef2736-912a-d83d-e063-dadaa90ab31f	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. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2912-2	Hydroxychloroquine sulfate	12 in 1 BOTTLE	TABLET, FILM COATED	12	4
68071-2912-3	Hydroxychloroquine sulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
68071-2912-9	Hydroxychloroquine sulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2912	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Legacy NDC, 3 package rows	20231121_f2002851-852f-4ee8-e053-2a95a90a242d.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Cardinal Health 107, LLC	6971241c-8323-456e-91a4-a404a9e100de	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Preferred Pharmaceuticals, Inc.	d6c8ee2e-116e-4167-8d1a-bd570a1ce672	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NuCare Pharmaceuticals, Inc.	4902343c-7d1b-ba70-e063-6294a90a3680	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Zydus Lifesciences Limited	1aa44bff-9a62-48b4-a520-98d7d524e3a9	2025-10-04		Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NuCare Pharmaceuticals,Inc.	b8e3a352-a1e3-e672-e053-2a95a90a641c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	6a06ad3d-2d6c-4e51-93f5-8f782b86975b	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	3817387f-2fc8-4f39-8096-3b48fff57ab0	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	53553ef5-5f44-4d39-ae8c-c9a632cc8416	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Asclemed USA, Inc.	19816051-c25e-44b5-a127-e846dbd0a8d8	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	American Health Packaging	a2d7be5a-98ee-4292-8715-46573dbe1c5b	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	f618a091-ade1-4c39-ab76-f6218b606e05	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NCS HealthCare of KY, LLC dba Vangard Labs	83cb17e9-ce57-48aa-b92c-ac0dee92d5bc	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	1a1fb21d-a01c-4d50-8764-cdd6c20d9569	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Northstar Rx LLC.	29ba0172-7ca3-4122-af1b-f0da522318cb	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Quallent Pharmaceuticals Health LLC	81e68f23-b1bf-4561-8f02-a472631acfaf	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Zydus Pharmaceuticals USA Inc.	805a1acd-2e0d-48f1-af6b-0e5d8e06c228	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	90111c26-cd12-4a45-a25f-8d83c83c80de	2020-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040657 application number: ANDA040657

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	f2002851-852f-4ee8-e053-2a95a90a242d	4
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	f2002851-852f-4ee8-e053-2a95a90a242d	4
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	f2002851-852f-4ee8-e053-2a95a90a242d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2912-9	68071291209	90 TABLET, FILM COATED in 1 BOTTLE (68071-2912-9)	2023-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine sulfate	NuCare Pharmaceuticals,Inc.	2023-11-20	HUMAN PRESCRIPTION DRUG LABEL	4