Plaquenil

Product NDC: 71610-473
11-digit product format: 716100473
Labeler code: 71610
Product ID: 71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA009768
Marketing category: NDA
Marketing start: 2013-06-28
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Plaquenil
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979092	Internal RxNorm lookup
979094	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
eb26c050-fc41-4183-9f8c-86351335fa64	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	SPL version
71610-473-04	Plaquenil	4000 in 1 BOTTLE	TABLET	4000	4
71610-473-30	Plaquenil	30 in 1 BOTTLE	TABLET	30	4
71610-473-53	Plaquenil	60 in 1 BOTTLE	TABLET	60	4
71610-473-74	Plaquenil	500 in 1 BOTTLE	TABLET	500	4
71610-473-80	Plaquenil	180 in 1 BOTTLE	TABLET	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-473-04	EA - Each	71610-473	56db209e-1224-42c2-ae6a-1a1fee20468d	1	2024-05-16
71610-473-74	EA - Each	71610-473	9d0396ca-3394-48e7-aa3e-3ceec09fd760	1	2024-01-04
71610-473-80	EA - Each	71610-473	fa5a5197-71d9-4166-9044-958c1e5c979d	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-473	PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Current NDC, Legacy NDC, 5 package rows	20240407_eb26c050-fc41-4183-9f8c-86351335fa64.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 ndc (product): 71610-473
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	eb26c050-fc41-4183-9f8c-86351335fa64	4
979094	Plaquenil 200 MG Oral Tablet	PSN	eb26c050-fc41-4183-9f8c-86351335fa64	4
979094	hydroxychloroquine sulfate 200 MG Oral Tablet [Plaquenil]	SBD	eb26c050-fc41-4183-9f8c-86351335fa64	4
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	eb26c050-fc41-4183-9f8c-86351335fa64	4
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	eb26c050-fc41-4183-9f8c-86351335fa64	4
979094	Plaquenil 200 MG Oral Tablet	SY	eb26c050-fc41-4183-9f8c-86351335fa64	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-473-04	71610047304	4000 TABLET in 1 BOTTLE (71610-473-04)	4000 tablet	2024-04-03		No	No	Current
71610-473-30	71610047330	30 TABLET in 1 BOTTLE (71610-473-30)	30 tablet	2020-10-14	0000-00-00	No	No	Current
71610-473-53	71610047353	60 TABLET in 1 BOTTLE (71610-473-53)	60 tablet	2020-10-14	0000-00-00	No	No	Current
71610-473-74	71610047374	500 TABLET in 1 BOTTLE (71610-473-74)	500 tablet	2023-03-24		No	No	Current
71610-473-80	71610047380	180 TABLET in 1 BOTTLE (71610-473-80)	180 tablet	2020-12-08	0000-00-00	No	No	Current