Thioridazine Hydrochloride

Product NDC: 70518-0770
Requested package NDC: 70518-0770-0
11-digit product format: 705180770
Labeler code: 70518
Product ID: 70518-0770_a587642c-83e7-090a-e053-2a95a90a360e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: thioridazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA088004
Marketing category: ANDA
Marketing start: 2017-10-09
Marketing end: 0000-00-00
Substance: THIORIDAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	70518-0770	70518-0770-0	D	Discontinued by firm		2026-10-05

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 43.

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	RLD / RS	Approval date
A088004-001	THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18
A088004-002	THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15
A088004-003	THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15
A088004-004	THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088004-001	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	RS	1983-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088004-002	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088004-003	THIORIDAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		1983-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088004-004	THIORIDAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		1983-03-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A088004-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A088004-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A088004-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A088004-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088004-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A088004-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A088004-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A088004-004	AB	1	`c0c555d07b60…`
2019-09-15 20:21 UTC	2019-09	A088004-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088004-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088004-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088004-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088004-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088004-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088004-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088004-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thioridazine Hydrochloride	THIORIDAZINE HYDROCHLORIDE	Safecor Health LLC	1fd16a99-e856-4a37-9dae-c443714fac14	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088004 application number: ANDA088004
Thioridazine Hydrochloride	THIORIDAZINE HYDROCHLORIDE	Mylan Institutional Inc.	52fea941-0b47-41c1-b00d-f88150e8ab93	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088004 application number: ANDA088004
Thioridazine Hydrochloride	THIORIDAZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	56b3f4c2-52af-4947-b225-6808ae9f26f5	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088004 application number: ANDA088004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4WCI67NK8M	THIORIDAZINE HYDROCHLORIDE	130-61-0	THIORIDAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0770-0	70518077000	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0770-0)	2017-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thioridazine Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2020-05-13	HUMAN PRESCRIPTION DRUG LABEL	4