HYDROXYCHLOROQUINE SULFATE

Product NDC: 50268-412
11-digit product format: 502680412
Labeler code: 50268
Product ID: 50268-412_47e560c6-bd1f-1264-e063-6394a90a0048
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYCHLOROQUINE SULFATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA210441
Marketing category: ANDA
Marketing start: 2020-05-15
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
A210441-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01
A210441-002	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19
A210441-003	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19
A210441-004	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210441-001	AB
A210441-002	AB
A210441-003	AB
A210441-004	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 3 · 119 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	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210441-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2018-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB	RS	2022-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2022-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB		2022-09-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 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	A210441-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210441-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210441-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210441-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210441-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210441-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210441-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210441-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210441-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210441-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210441-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210441-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210441-004	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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979092	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
a5b3455a-e842-7d4b-e053-2995a90adee3	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
50268-412-11	HYDROXYCHLOROQUINE SULFATE	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		4
50268-412-15	HYDROXYCHLOROQUINE SULFATE	50 in 1 BOX	TABLET, FILM COATED	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-412-11	EA - Each	50268-412	f171f71b-5422-4b86-aa84-0ba1a1e96645	1	2020-06-05
50268-412-15	EA - Each	50268-412	36206e51-a943-4051-99c5-590b12b1761d	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-412	HYDROXYCHLOROQUINE SULFATE TABLET [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20240110_a5b3455a-e842-7d4b-e053-2995a90adee3.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Cardinal Health 107, LLC	e5fe2ece-40a1-49eb-818f-62ff3c3bb199	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	AvPAK	a5b3455a-e842-7d4b-e053-2995a90adee3	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441 ndc (product): 50268-412
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Dr. Reddy's Laboratories Inc.	452092b4-7a8f-4d19-8113-f1c2a948d3d8	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Major Pharmaceuticals	ebe00e35-ed3d-40f4-9a93-a37b0da01ddb	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	2c109188-d28b-4c65-8b52-819bd8547f2e	2024-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	beff29fe-574f-4566-99ac-53ec3b3038a7	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210441 application number: ANDA210441

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	a5b3455a-e842-7d4b-e053-2995a90adee3	4
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	a5b3455a-e842-7d4b-e053-2995a90adee3	4
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	a5b3455a-e842-7d4b-e053-2995a90adee3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-412-11	50268041211	1 in 1 BLISTER PACK						Historical
50268-412-15	50268041215	50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)	50 blister pack	2020-05-15	0000-00-00	No	No	Current