HYDROXYCHLOROQUINE SULFATE

Product NDC: 71335-3113
11-digit product format: 713353113
Labeler code: 71335
Product ID: 71335-3113_b620fa12-9bce-484e-b2f1-02bb6d8315be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxychloroquine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040150
Marketing category: ANDA
Marketing start: 2025-05-08
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040150-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		1996-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040150-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1996-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040150-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1996-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040150-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040150-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040150-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040150-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040150-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040150-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040150-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040150-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040150-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040150-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040150-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040150-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040150-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040150-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040150-001	AB	1	`a50c72e98297…`

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
1a39c45e-dc14-4441-9b02-7329647bc5a4	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
71335-3113-1	HYDROXYCHLOROQUINE SULFATE	100 in 1 BOTTLE	TABLET	100	1
71335-3113-2	HYDROXYCHLOROQUINE SULFATE	30 in 1 BOTTLE	TABLET	30	1
71335-3113-3	HYDROXYCHLOROQUINE SULFATE	60 in 1 BOTTLE	TABLET	60	1
71335-3113-4	HYDROXYCHLOROQUINE SULFATE	180 in 1 BOTTLE	TABLET	180	1
71335-3113-5	HYDROXYCHLOROQUINE SULFATE	90 in 1 BOTTLE	TABLET	90	1
71335-3113-6	HYDROXYCHLOROQUINE SULFATE	120 in 1 BOTTLE	TABLET	120	1
71335-3113-7	HYDROXYCHLOROQUINE SULFATE	10 in 1 BOTTLE	TABLET	10	1
71335-3113-8	HYDROXYCHLOROQUINE SULFATE	14 in 1 BOTTLE	TABLET	14	1
71335-3113-9	HYDROXYCHLOROQUINE SULFATE	20 in 1 BOTTLE	TABLET	20	1

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	Bryant Ranch Prepack	68d6439d-b927-47e6-86ef-20e572e81941	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	1a39c45e-dc14-4441-9b02-7329647bc5a4	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150 ndc (product): 71335-3113
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	517ee47b-6abf-43cb-a4ca-c2e7827461a8	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Creekwood Pharmaceuticals LLC	04139607-f7c0-4fe1-a210-ffa5af347d56	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	f95cfc03-5023-44b3-8994-25afac18b734	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	84957919-ca14-4c3d-b4fe-452ff330dd7a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040150 application number: ANDA040150

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	1a39c45e-dc14-4441-9b02-7329647bc5a4	1
979092	hydroxychloroquine sulfate 200 MG Oral Tablet	SCD	1a39c45e-dc14-4441-9b02-7329647bc5a4	1
979092	hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet	SY	1a39c45e-dc14-4441-9b02-7329647bc5a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3113-1	71335311301	100 TABLET in 1 BOTTLE (71335-3113-1)	100 tablet	2026-03-30	No	No	Current
71335-3113-2	71335311302	30 TABLET in 1 BOTTLE (71335-3113-2)	30 tablet	2026-03-30	No	No	Current
71335-3113-3	71335311303	60 TABLET in 1 BOTTLE (71335-3113-3)	60 tablet	2026-03-30	No	No	Current
71335-3113-4	71335311304	180 TABLET in 1 BOTTLE (71335-3113-4)	180 tablet	2026-03-30	No	No	Current
71335-3113-5	71335311305	90 TABLET in 1 BOTTLE (71335-3113-5)	90 tablet	2026-03-30	No	No	Current
71335-3113-6	71335311306	120 TABLET in 1 BOTTLE (71335-3113-6)	120 tablet	2026-03-30	No	No	Current
71335-3113-7	71335311307	10 TABLET in 1 BOTTLE (71335-3113-7)	10 tablet	2026-03-30	No	No	Current
71335-3113-8	71335311308	14 TABLET in 1 BOTTLE (71335-3113-8)	14 tablet	2026-03-30	No	No	Current
71335-3113-9	71335311309	20 TABLET in 1 BOTTLE (71335-3113-9)	20 tablet	2026-03-30	No	No	Current