Home NDC 70954-016 Thiothixene
Product NDC 70954-016
11-digit product format 709540016
Labeler code 70954
Product ID 70954-016_92792cc3-5d0e-4105-bf5a-03f2e479b8d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiothixene
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA211642
Marketing category ANDA
Marketing start 2019-04-05
Substance THIOTHIXENE
Active strength 5 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.
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.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Thiothixene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THIOTHIXENE 5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313361 Internal RxNorm lookup 313362 Internal RxNorm lookup 313364 Internal RxNorm lookup 313366 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-016-10 Thiothixene 100 in 1 BOTTLE CAPSULE 100 4 70954-016-20 Thiothixene 1000 in 1 BOTTLE CAPSULE 1000 4 70954-016-30 Thiothixene 1 in 1 BLISTER PACK CAPSULE 1 4 70954-016-40 Thiothixene 100 in 1 CARTON CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-016 THIOTHIXENE CAPSULE [ANI PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20250227_b067b400-66cd-422d-a631-9ce0c935d2b2.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 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 ndc (product): 70954-016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-016-10 70954001610 100 CAPSULE in 1 BOTTLE (70954-016-10) 100 capsule 2019-04-05 0000-00-00 No No Current 70954-016-20 70954001620 1000 CAPSULE in 1 BOTTLE (70954-016-20) 1000 capsule 2019-04-05 0000-00-00 No No Current 70954-016-30 70954001630 1 in 1 BLISTER PACK Historical 70954-016-40 70954001640 100 BLISTER PACK in 1 CARTON (70954-016-40) / 1 CAPSULE in 1 BLISTER PACK (70954-016-30) 100 blister pack 2020-08-28 0000-00-00 No No Current