Thiothixene

Product NDC
53808-1129
11-digit product format
538081129
Labeler code
53808
Product ID
53808-1129_afb8454e-98a4-4fc3-9be7-05c59a82e294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiothixene
Dosage form
CAPSULE
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA071093
Marketing category
ANDA
Marketing start
2017-06-28
Marketing end
0000-00-00
Substance
THIOTHIXENE
Active strength
2 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-1129IInactivated by FDA2026-09-14
excluded packagepackage53808-112953808-1129-1IInactivated by FDA2026-09-14

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-1129-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-1129-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-1129-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-1129-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-1129-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-1129-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-1129-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-1129-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-1129-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-1129-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-1129-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-1129-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-1129-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-1129-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-1129-11332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071093-001THIOTHIXENETHIOTHIXENE10MGCAPSULE / ORALAB1987-06-23
A071093-002THIOTHIXENETHIOTHIXENE1MGCAPSULE / ORALAB1987-06-23
A071093-003THIOTHIXENETHIOTHIXENE2MGCAPSULE / ORALAB1987-06-23
A071093-004THIOTHIXENETHIOTHIXENE5MGCAPSULE / ORALAB1987-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071093-001AB
A071093-002AB
A071093-003AB
A071093-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-001THIOTHIXENE10MGCAPSULE / ORALAB1987-06-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-002THIOTHIXENE1MGCAPSULE / ORALAB1987-06-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-003THIOTHIXENE2MGCAPSULE / ORALAB1987-06-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-004THIOTHIXENE5MGCAPSULE / ORALAB1987-06-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071093-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A071093-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A071093-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A071093-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A071093-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071093-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071093-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071093-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071093-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071093-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071093-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071093-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071093-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071093-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071093-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071093-004AB15bbf6a4d5a75…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5299972-3372-4536-b6da-1420f7d91760Product name220221213

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1129-12024-01-30C16284748780-11030e365-65f4-111a-e063-dadaa90a10e2d9909bb6-3ccd-487c-8228-f955135ed38f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1129-1Thiothixene30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1129THIOTHIXENE CAPSULE [DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20190129_d9909bb6-3ccd-487c-8228-f955135ed38f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313364thiothixene 2 MG Oral CapsulePSNd9909bb6-3ccd-487c-8228-f955135ed38f2
313364thiothixene 2 MG Oral CapsuleSCDd9909bb6-3ccd-487c-8228-f955135ed38f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53808-1129-15380811290130 CAPSULE in 1 BLISTER PACK (53808-1129-1) 30 capsule2017-06-280000-00-00NoNoCurrent