Hydroxychloroquine Sulfate

Product NDC: 63304-296
11-digit product format: 633040296
Labeler code: 63304
Product ID: 63304-296_1075d173-e155-493c-8e50-08fdf8a73860
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040766
Marketing category: ANDA
Marketing start: 2009-01-07
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: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-296		D	Discontinued by firm	2026-08-17
excluded package	package	63304-296	63304-296-01	D	Discontinued by firm	2026-08-17
excluded package	package	63304-296	63304-296-03	D	Discontinued by firm	2026-08-17
excluded package	package	63304-296	63304-296-05	D	Discontinued by firm	2026-08-17
excluded package	package	63304-296	63304-296-10	D	Discontinued by firm	2026-08-17

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 · 60 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-296-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-296-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-296-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-296-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-296-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-296-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-296-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-296-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-296-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-296-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-296-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-296-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-296-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-296-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-296-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-296-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-296-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-296-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-296-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-296-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-296-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-296-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-296-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-296-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-296-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-296-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-296-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-296-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-296-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-296-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-296-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-296-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-296-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-296-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-296-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-296-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-296-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-296-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-296-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-296-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-296-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-296-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-296-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-296-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-296-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-296-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-296-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-296-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040766-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2007-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040766-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040766-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040766-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	AB	1	`e64feba35796…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-296-01	EA - Each	63304-296	cade17b6-d86c-41c3-a206-6072876dca62	1	2012-07-24
63304-296-05	EA - Each	63304-296	7770863e-ca52-44f3-ad27-7dfd9e292ebc	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 [RANBAXY PHARMACEUTICALS INC.]	4
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	4
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYCHLOROQUINE SULFATE	ACTIVE INGREDIENT	8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYCHLOROQUINE	ACTIVE MOIETY	4QWG6N8QKH	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1

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 · 3 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	37413f6b-fb68-4e0c-8bcc-c5b76e956dfc	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Coupler LLC	2eeaf562-95f9-bcef-e063-6394a90a1c19	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Ipca Laboratories Limited	9dfa0ff8-e8cf-47f9-847a-b86f23dc39df	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766

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	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	f0dbb1c2-cdb6-4bf5-9190-3be68da19c9e	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate Tablets, USP	DOH CENTRAL PHARMACY	2019-01-29	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxychloroquine Sulfate Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Ipca Laboratories Limited \| Ohm Laboratories Inc.	2018-07-23	HUMAN PRESCRIPTION DRUG LABEL	5
Hydroxychloroquine Sulfate Tablets, USP	A-S Medication Solutions	2017-10-13	HUMAN PRESCRIPTION DRUG LABEL	5
Hydroxychloroquine Sulfate Tablets, USP	Blenheim Pharmacal, Inc.	2015-02-24	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxychloroquine Sulfate Tablets, USP	Aidarex Pharmaceuticals LLC	2014-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxychloroquine Sulfate Tablets, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-27	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxychloroquine Sulfate Tablets, USP	Rebel Distributors Corp	2010-09-29	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxychloroquine Sulfate Tablets, USP	Physicians Total Care, Inc.	2010-01-07	HUMAN PRESCRIPTION DRUG LABEL	2