Hydroxychloroquine Sulfate

Product NDC: 71335-1523
11-digit product format: 713351523
Labeler code: 71335
Product ID: 71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210577
Marketing category: ANDA
Marketing start: 2018-05-17
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

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1523-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1523-4	`1332a3947898…`	`d4bfe170f9cd…`

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
A210577-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210577-001	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	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210577-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2018-05-15	`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	A210577-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210577-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210577-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210577-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210577-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210577-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210577-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210577-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210577-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210577-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210577-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210577-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210577-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210577-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210577-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210577-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210577-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210577-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210577-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210577-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210577-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210577-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210577-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210577-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210577-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210577-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210577-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210577-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210577-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210577-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210577-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210577-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210577-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210577-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210577-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210577-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210577-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210577-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210577-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210577-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxychloroquine Sulfate
Listing expiration: 2027-12-31

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
da435181-0c5a-4188-8d59-51234116b005	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83	Product name	1	20220928
79a2ab33-ef76-b1c3-49e7-8533315e153b	Product name	5	20200716
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-1523-1	2024-05-20	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
71335-1523-1	2024-05-20	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
71335-1523-2	2024-05-20	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
71335-1523-2	2024-05-20	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
71335-1523-3	2024-05-20	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
71335-1523-3	2024-05-20	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
71335-1523-4	2024-05-20	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
71335-1523-4	2024-05-20	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
71335-1523-5	2024-05-20	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
71335-1523-5	2024-05-20	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
71335-1523-6	2024-05-20	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
71335-1523-6	2024-05-20	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
71335-1523-7	2024-05-20	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
71335-1523-7	2024-05-20	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
71335-1523-8	2024-05-20	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
71335-1523-8	2024-05-20	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
71335-1523-9	2024-05-20	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
71335-1523-9	2024-05-20	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
71335-1523-1	2024-01-30	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
71335-1523-1	2024-01-30	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
71335-1523-2	2024-01-30	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
71335-1523-2	2024-01-30	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
71335-1523-3	2024-01-30	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
71335-1523-3	2024-01-30	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
71335-1523-4	2024-01-30	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
71335-1523-4	2024-01-30	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
71335-1523-5	2024-01-30	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
71335-1523-5	2024-01-30	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
71335-1523-6	2024-01-30	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
71335-1523-6	2024-01-30	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
71335-1523-7	2024-01-30	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
71335-1523-7	2024-01-30	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
71335-1523-8	2024-01-30	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
71335-1523-8	2024-01-30	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
71335-1523-9	2024-01-30	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
71335-1523-9	2024-01-30	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1523-1	Hydroxychloroquine Sulfate	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
71335-1523-2	Hydroxychloroquine Sulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
71335-1523-3	Hydroxychloroquine Sulfate	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
71335-1523-4	Hydroxychloroquine Sulfate	180 in 1 BOTTLE	TABLET, FILM COATED	180	8
71335-1523-5	Hydroxychloroquine Sulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
71335-1523-6	Hydroxychloroquine Sulfate	120 in 1 BOTTLE	TABLET, FILM COATED	120	8
71335-1523-7	Hydroxychloroquine Sulfate	10 in 1 BOTTLE	TABLET, FILM COATED	10	8
71335-1523-8	Hydroxychloroquine Sulfate	14 in 1 BOTTLE	TABLET, FILM COATED	14	8
71335-1523-9	Hydroxychloroquine Sulfate	20 in 1 BOTTLE	TABLET, FILM COATED	20	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1523	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 9 package rows	20240522_da435181-0c5a-4188-8d59-51234116b005.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	da435181-0c5a-4188-8d59-51234116b005	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210577 application number: ANDA210577 ndc (product): 71335-1523
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	87076a61-ce76-475b-ac6d-c33ba617195d	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210577 application number: ANDA210577
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Amneal Pharmaceuticals NY LLC	7804f5d2-41a6-4523-a277-6967e984e88e	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210577 application number: ANDA210577
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	427ac2fc-8f7f-9725-e063-6394a90a381b	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210577 application number: ANDA210577
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Amneal Pharmaceuticals NY LLC	6a9e2fc8-bedf-46d4-9973-328dbcb18061	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210577 application number: ANDA210577

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	da435181-0c5a-4188-8d59-51234116b005	8
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	da435181-0c5a-4188-8d59-51234116b005	8
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	da435181-0c5a-4188-8d59-51234116b005	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1523-1	71335152301	100 TABLET, FILM COATED in 1 BOTTLE (71335-1523-1)	2020-03-26	0000-00-00	No	No	Current
71335-1523-2	71335152302	30 TABLET, FILM COATED in 1 BOTTLE (71335-1523-2)	2020-03-13	0000-00-00	No	No	Current
71335-1523-3	71335152303	60 TABLET, FILM COATED in 1 BOTTLE (71335-1523-3)	2020-08-03	0000-00-00	No	No	Current
71335-1523-4	71335152304	180 TABLET, FILM COATED in 1 BOTTLE (71335-1523-4)	2022-09-21	0000-00-00	No	No	Current
71335-1523-5	71335152305	90 TABLET, FILM COATED in 1 BOTTLE (71335-1523-5)	2020-02-26	0000-00-00	No	No	Current
71335-1523-6	71335152306	120 TABLET, FILM COATED in 1 BOTTLE (71335-1523-6)	2022-09-21	0000-00-00	No	No	Current
71335-1523-7	71335152307	10 TABLET, FILM COATED in 1 BOTTLE (71335-1523-7)	2022-09-21	0000-00-00	No	No	Current
71335-1523-8	71335152308	14 TABLET, FILM COATED in 1 BOTTLE (71335-1523-8)	2022-09-21	0000-00-00	No	No	Current
71335-1523-9	71335152309	20 TABLET, FILM COATED in 1 BOTTLE (71335-1523-9)	2022-09-21	0000-00-00	No	No	Current