Hydroxychloroquine sulfate

Product NDC: 63739-777
11-digit product format: 637390777
Labeler code: 63739
Product ID: 63739-777_d2ce07e8-8051-c01a-e053-2995a90a22b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
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: Antirheumatic Agent [EPC],Antimalarial [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-777		D	Discontinued by firm		2026-08-03
excluded package	package	63739-777	63739-777-10	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	63739-777		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63739-777	63739-777-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-777-10	2020-07-22	C162847	48780-1	ab0e2407-2f0f-f274-e053-dbdaa90a6471	HIGHLIGHTS OF PRESCRIBING INFORMATION 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
63739-777-10	EA - Each	63739-777	e04d993b-4f54-40ca-935b-3c09b1636c4a	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-777	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]	13	Legacy NDC	20241228_b47e12d3-0395-4462-b856-2ecb033f11e6.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-777-10	63739077710	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-777-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2015-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine sulfate	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	13