Hydroxychloroquine Sulfate

Product NDC: 43353-051
Requested package NDC: 43353-051-60
11-digit product format: 433530051
Labeler code: 43353
Product ID: 43353-051_185f5714-9f7b-4570-8047-0ba6994a6dc4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA009768
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-12-12
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-051	43353-051-60	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-051	43353-051-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-051	43353-051-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
N009768-001	PLAQUENIL	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009768-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N009768-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009768-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009768-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009768-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009768-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009768-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009768-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009768-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009768-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009768-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009768-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009768-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009768-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009768-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009768-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009768-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009768-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009768-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009768-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009768-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009768-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009768-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009768-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009768-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009768-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009768-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009768-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009768-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009768-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009768-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009768-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009768-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009768-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009768-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009768-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009768-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009768-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009768-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009768-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N009768-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-051-09	HYDROXYCHLOROQUINE SULFATE TABLETS, USP
43353-051-53	HYDROXYCHLOROQUINE SULFATE TABLETS, USP
43353-051-60	HYDROXYCHLOROQUINE SULFATE TABLETS, USP
43353-051-80	HYDROXYCHLOROQUINE SULFATE TABLETS, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-051-09	EA - Each	43353-051	a3eae686-a9fb-4f7e-bc8b-7afbd0793727	1	2016-09-02
43353-051-53	EA - Each	43353-051	6329eac2-6266-4cc5-acd1-858a07515480	1	2016-07-19
43353-051-60	EA - Each	43353-051	b5f9c5ed-2d67-4091-bc0e-de9f45b63bf4	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-051	HYDROXYCHLOROQUINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC	20200417_00ab155c-60b7-4527-acc4-316c6b2efa8a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Advanz Pharma (US) Corp.	34496b43-05a2-45fb-a769-52b12e099341	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	eb26c050-fc41-4183-9f8c-86351335fa64	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Proficient Rx LP	8aec894d-5711-4079-b167-240713bf04f2	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE	747-36-4	HYDROXYCHLOROQUINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-051-60	43353005160	90 TABLET in 1 BOTTLE (43353-051-60)	90 tablet	2015-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXYCHLOROQUINE SULFATE TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2020-04-13	Human Prescription Drug Label	3