Thiothixene

Product NDC: 67046-1542
11-digit product format: 670461542
Labeler code: 67046
Product ID: 67046-1542_313e882a-0ba6-354c-e063-6294a90a0a3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Thiothixene
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA211642
Marketing category: ANDA
Marketing start: 2025-03-26
Substance: THIOTHIXENE
Active strength: 10 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
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	TE codes	RLD / RS	Approval date
A211642-001	THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05
A211642-002	THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05
A211642-003	THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05
A211642-004	THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211642-001	AB
A211642-002	AB
A211642-003	AB
A211642-004	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211642-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211642-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211642-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211642-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211642-001	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-002	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-003	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-004	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211642-001	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-002	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-003	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-004	CGT	2019-10-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211642-001	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-002	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-003	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-004	CGT	2019-10-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211642-001	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-002	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-003	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-004	CGT	2019-10-02	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Thiothixene
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THIOTHIXENE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7318FJ13YJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313361	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
313e893c-a6d0-46ae-e063-6294a90a6025	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b5299972-3372-4536-b6da-1420f7d91760	Product name	2	20221213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1542-3	Thiothixene	30 in 1 BLISTER PACK	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1542	THIOTHIXENE CAPSULE [COUPLER LLC]	1	Current NDC, 1 package rows	20250327_313e893c-a6d0-46ae-e063-6294a90a6025.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
Thiothixene	THIOTHIXENE	Golden State Medical Supply, Inc.	9480a406-c85b-ba06-e053-2a95a90a0912	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642
Thiothixene	THIOTHIXENE	Coupler LLC	313e893c-a6d0-46ae-e063-6294a90a6025	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642 ndc (product): 67046-1542
Thiothixene	THIOTHIXENE	ANI Pharmaceuticals, Inc.	b067b400-66cd-422d-a631-9ce0c935d2b2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7318FJ13YJ	THIOTHIXENE	3313-26-6	THIOTHIXENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313361	thiothixene 10 MG Oral Capsule	PSN	313e893c-a6d0-46ae-e063-6294a90a6025	1
313361	thiothixene 10 MG Oral Capsule	SCD	313e893c-a6d0-46ae-e063-6294a90a6025	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1542-3	67046154203	30 CAPSULE in 1 BLISTER PACK (67046-1542-3)	30 capsule	2025-03-26	No	No	Current