Hydroxychloroquine Sulfate

Product NDC: 16729-485
Requested package NDC: 16729-485-01
11-digit product format: 167290485
Labeler code: 16729
Product ID: 16729-485_4e68b971-e226-d3ff-e063-6294a90ae772
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare, Inc.,
Application: ANDA213342
Marketing category: ANDA
Marketing start: 2020-05-12
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 200 mg/1
Pharmacologic classes: Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213342-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07
A213342-002	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18
A213342-003	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18
A213342-004	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213342-001	AB
A213342-002	AB
A213342-003	AB
A213342-004	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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	A213342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213342-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Accord Healthcare, Inc.,	84b00366-96ef-41e1-bac6-5d24acdb9e1d	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213342 application number: ANDA213342 ndc (package): 16729-485-01 ndc (product): 16729-485 ndc11 (package): 16729048501
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	b4dca05a-745f-4c15-b731-1e99176cf44c	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213342 application number: ANDA213342

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979092	Internal RxNorm lookup
1119312	Internal RxNorm lookup
2569281	Internal RxNorm lookup
2569283	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
84b00366-96ef-41e1-bac6-5d24acdb9e1d	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
16729-485-01	Hydroxychloroquine Sulfate	100 in 1 BOTTLE	TABLET	100		10
16729-485-16	Hydroxychloroquine Sulfate	500 in 1 BOTTLE	TABLET	500		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-485-01	EA - Each	16729-485	e87922f0-90d5-4e74-9abb-9fcf52406f98	1	2020-05-08
16729-485-16	EA - Each	16729-485	5bb96aa9-313c-4377-9737-0669e8eedf95	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-485	HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,]	8	Current NDC, Legacy NDC, 2 package rows	20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.zip

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
2569281	hydroxychloroquine sulfate 100 MG Oral Tablet	PSN	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
2569283	hydroxychloroquine sulfate 300 MG Oral Tablet	PSN	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
1119312	hydroxychloroquine sulfate 400 MG Oral Tablet	PSN	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
2569281	hydroxychloroquine sulfate 100 MG Oral Tablet	SCD	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
2569283	hydroxychloroquine sulfate 300 MG Oral Tablet	SCD	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
1119312	hydroxychloroquine sulfate 400 MG Oral Tablet	SCD	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	84b00366-96ef-41e1-bac6-5d24acdb9e1d	10
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	PSN	b4dca05a-745f-4c15-b731-1e99176cf44c	3
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	b4dca05a-745f-4c15-b731-1e99176cf44c	3
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	b4dca05a-745f-4c15-b731-1e99176cf44c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-485-01	16729048501	100 TABLET in 1 BOTTLE (16729-485-01)	100 tablet	2021-01-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate	Accord Healthcare, Inc., \| Intas Pharmaceuticals Limited	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	10
Hydroxychloroquine Sulfate	A-S Medication Solutions	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxychloroquine Sulfate	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-10	HUMAN PRESCRIPTION DRUG LABEL	4