Hydroxychloroquine Sulfate

Product NDC: 68084-269
Requested package NDC: 68084-269-01
11-digit product format: 680840269
Labeler code: 68084
Product ID: 68084-269_1ea6084a-c32f-e654-e063-6394a90ad851
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA040657
Marketing category: ANDA
Marketing start: 2008-09-03
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 200 mg/1
Pharmacologic classes: Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxychloroquine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYCHLOROQUINE SULFATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8Q2869CNVH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979092	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a2d7be5a-98ee-4292-8715-46573dbe1c5b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-269-01	Hydroxychloroquine Sulfate	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		10
68084-269-11	Hydroxychloroquine Sulfate	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-269-01	EA - Each	68084-269	c1b4239e-0201-4786-8e1b-5fba21642a7d	1	2012-07-24
68084-269-11	EA - Each	68084-269	64d9b010-5c7b-486e-86a7-02d27b89616e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH]	6
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-269	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 2 package rows	20240805_a2d7be5a-98ee-4292-8715-46573dbe1c5b.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 ndc (package): 68084-269-01 ndc (product): 68084-269 ndc11 (package): 68084026901
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	6971241c-8323-456e-91a4-a404a9e100de	16
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	6971241c-8323-456e-91a4-a404a9e100de	16
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	6971241c-8323-456e-91a4-a404a9e100de	16
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	a2d7be5a-98ee-4292-8715-46573dbe1c5b	10
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	a2d7be5a-98ee-4292-8715-46573dbe1c5b	10
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	a2d7be5a-98ee-4292-8715-46573dbe1c5b	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-269-01	68084026901	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-269-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-269-11)	100 blister pack	2008-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine sulfate	Cardinal Health 107, LLC	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	16
Hydroxychloroquine Sulfate	American Health Packaging	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	10