Thioridazine Hydrochloride

Product NDC: 51079-580
11-digit product format: 510790580
Labeler code: 51079
Product ID: 51079-580_4358c933-3022-792d-e063-6294a90aacb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: thioridazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA088004
Marketing category: ANDA
Marketing start: 1998-06-22
Substance: THIORIDAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

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
52fea941-0b47-41c1-b00d-f88150e8ab93	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
51079-580-01	Thioridazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		15
51079-580-20	Thioridazine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-580-01	EA - Each	51079-580	9daf510e-438c-4ed2-a5fd-85f3b5593b48	1	2012-07-24
51079-580-20	EA - Each	51079-580	7ed5e712-ae69-406e-844e-79e7b708cb4c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THIORIDAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	4WCI67NK8M	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
THIORIDAZINE	ACTIVE MOIETY	N3D6TG58NI	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-580	THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	13	Current NDC, Legacy NDC, 2 package rows	20211217_52fea941-0b47-41c1-b00d-f88150e8ab93.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 · 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 ndc (product): 51079-580
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	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198270	thioridazine HCl 100 MG Oral Tablet	PSN	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198274	thioridazine HCl 25 MG Oral Tablet	PSN	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198275	thioridazine HCl 50 MG Oral Tablet	PSN	52fea941-0b47-41c1-b00d-f88150e8ab93	15
313354	thioridazine 10 MG Oral Tablet	SCD	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198270	thioridazine 100 MG Oral Tablet	SCD	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198274	thioridazine 25 MG Oral Tablet	SCD	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198275	thioridazine 50 MG Oral Tablet	SCD	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198274	thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet	SY	52fea941-0b47-41c1-b00d-f88150e8ab93	15
198275	thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet	SY	52fea941-0b47-41c1-b00d-f88150e8ab93	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-580-01	51079058001	1 in 1 BLISTER PACK						Historical
51079-580-20	51079058020	100 BLISTER PACK in 1 CARTON (51079-580-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-580-01)	100 blister pack	1998-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thioridazine Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	15