Thioridazine Hydrochloride

Product NDC: 48433-098
11-digit product format: 484330098
Labeler code: 48433
Product ID: 48433-098_4c13278f-8a01-f1b7-e063-6394a90ac5b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: thioridazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA088004
Marketing category: ANDA
Marketing start: 2026-02-19
Substance: THIORIDAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
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 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Thioridazine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THIORIDAZINE HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4WCI67NK8M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198270	Internal RxNorm lookup
198274	Internal RxNorm lookup
198275	Internal RxNorm lookup
313354	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
1fd16a99-e856-4a37-9dae-c443714fac14	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92b3bc4b-cbea-b9aa-f31b-a4133eb6e99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-098-01	Thioridazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
48433-098-20	Thioridazine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		2

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 ndc (product): 48433-098
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313354	thioridazine HCl 10 MG Oral Tablet	PSN	1fd16a99-e856-4a37-9dae-c443714fac14	2
198270	thioridazine HCl 100 MG Oral Tablet	PSN	1fd16a99-e856-4a37-9dae-c443714fac14	2
198274	thioridazine HCl 25 MG Oral Tablet	PSN	1fd16a99-e856-4a37-9dae-c443714fac14	2
198275	thioridazine HCl 50 MG Oral Tablet	PSN	1fd16a99-e856-4a37-9dae-c443714fac14	2
313354	thioridazine 10 MG Oral Tablet	SCD	1fd16a99-e856-4a37-9dae-c443714fac14	2
198270	thioridazine 100 MG Oral Tablet	SCD	1fd16a99-e856-4a37-9dae-c443714fac14	2
198274	thioridazine 25 MG Oral Tablet	SCD	1fd16a99-e856-4a37-9dae-c443714fac14	2
198275	thioridazine 50 MG Oral Tablet	SCD	1fd16a99-e856-4a37-9dae-c443714fac14	2
198274	thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet	SY	1fd16a99-e856-4a37-9dae-c443714fac14	2
198275	thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet	SY	1fd16a99-e856-4a37-9dae-c443714fac14	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-098-01	48433009801	1 in 1 BLISTER PACK					Historical
48433-098-20	48433009820	100 BLISTER PACK in 1 CARTON (48433-098-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-098-01)	100 blister pack	2026-02-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thioridazine Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	2