Hydroxychloroquine Sulfate

Product NDC: 70954-171
Requested package NDC: 70954-171-10
11-digit product format: 709540171
Labeler code: 70954
Product ID: 70954-171_9f450277-70b2-4721-88ec-df1bf3fe5262
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxychloroquine Sulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novitium Pharma LLC
Application: NDA214581
Marketing category: NDA
Marketing start: 2022-01-14
Marketing end: 0000-00-00
Substance: HYDROXYCHLOROQUINE SULFATE
Active strength: 300 mg/1
Pharmacologic classes: Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70954-171	70954-171-10	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214581-001	SOVUNA	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		RLD	2022-01-14
N214581-002	SOVUNA	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL		RLD, RS	2022-01-14

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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`1c564ffb4f44…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOVUNA	HYDROXYCHLOROQUINE SULFATE	ANI Pharmaceuticals, Inc.	dd441154-b196-4d4c-bc56-2e37f345ef8d	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214581 application number: NDA214581

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8Q2869CNVH	HYDROXYCHLOROQUINE SULFATE	747-36-4	HYDROXYCHLOROQUINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-171-10	70954017110	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70954-171-10)	2022-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxychloroquine Sulfate	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2023-07-12	Human Prescription Drug Label	5