Hydroxychloroquine Sulfate

Product NDC: 16729-561
Requested package NDC: 16729-561-01
11-digit product format: 167290561
Labeler code: 16729
Product ID: 16729-561_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: 2021-09-28
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 100 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…`

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	100 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
16729-561-01	Hydroxychloroquine Sulfate	100 in 1 BOTTLE	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-561-01	EA - Each	16729-561	fb694cfd-bd65-4b23-9222-cb4b52c8d889	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-561	HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,]	8	Current NDC, Legacy NDC, 1 package rows	20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.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 · 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): 16729-561-01 ndc (product): 16729-561 ndc11 (package): 16729056101
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-561-01	16729056101	100 TABLET in 1 BOTTLE (16729-561-01)	100 tablet	2021-09-28	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