Hydroxychloroquine sulfate

Product NDC: 57664-761
11-digit product format: 576640761
Labeler code: 57664
Product ID: 57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201691
Marketing category: ANDA
Marketing start: 2018-06-18
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
A201691-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201691-001	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	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201691-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-08	`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	A201691-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201691-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201691-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201691-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201691-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201691-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201691-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201691-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201691-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201691-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201691-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201691-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201691-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201691-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201691-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201691-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201691-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201691-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201691-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201691-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201691-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201691-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201691-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201691-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201691-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201691-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201691-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201691-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201691-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201691-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201691-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201691-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201691-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201691-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201691-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201691-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201691-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201691-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201691-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201691-001	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
6e72fe06-7995-3fd7-e053-2a91aa0a54db	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
57664-761-13	Hydroxychloroquine sulfate	500 in 1 BOTTLE	TABLET	500		8
57664-761-88	Hydroxychloroquine sulfate	100 in 1 BOTTLE	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-761-13	EA - Each	57664-761	57a287ea-e931-4621-a680-a683e34ef166	1	2018-07-03
57664-761-88	EA - Each	57664-761	22c0c439-f4d0-4c9f-9005-16462ae49dff	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-761	HYDROXYCHLOROQUINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20221112_6e72fe06-7995-3fd7-e053-2a91aa0a54db.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Sun Pharmaceutical Industries, Inc.	6e72fe06-7995-3fd7-e053-2a91aa0a54db	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201691 application number: ANDA201691 ndc (product): 57664-761

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	6e72fe06-7995-3fd7-e053-2a91aa0a54db	8
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	6e72fe06-7995-3fd7-e053-2a91aa0a54db	8
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	6e72fe06-7995-3fd7-e053-2a91aa0a54db	8
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	fe39f2c0-1b3d-486b-ad59-f88b28404d32	3
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	fe39f2c0-1b3d-486b-ad59-f88b28404d32	3
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	fe39f2c0-1b3d-486b-ad59-f88b28404d32	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-761-13	57664076113	500 TABLET in 1 BOTTLE (57664-761-13)	500 tablet	2018-06-18	0000-00-00	No	No	Current
57664-761-88	57664076188	100 TABLET in 1 BOTTLE (57664-761-88)	100 tablet	2018-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine sulfate	Sun Pharmaceutical Industries, Inc. \| ALKALOIDA chemical company Zrt	2022-11-11	Human Prescription Drug Label	8
Hydroxychloroquine sulfate	PD-Rx Pharmaceuticals, Inc.	2022-03-25	HUMAN PRESCRIPTION DRUG LABEL	8
HYDROXYCHLOROQUINE SULFATE - A-S Medication Solutions	A-S Medication Solutions	2021-03-02	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROXYCHLOROQUINE SULFATE	DIRECT RX	2020-03-23	HUMAN PRESCRIPTION DRUG LABEL	1