Home NDC 60219-1675 thiothixene
Product NDC 60219-1675
11-digit product format 602191675
Labeler code 60219
Product ID 60219-1675_2a200fb2-9cdb-46c4-ad0f-5e3e89c3210d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name thiothixene
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA215456
Marketing category ANDA
Marketing start 2022-03-03
Substance THIOTHIXENE
Active strength 5 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
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 TE codes RLD / RS Approval date A215456-001 THIOTHIXENE THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 A215456-002 THIOTHIXENE THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 A215456-003 THIOTHIXENE THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 A215456-004 THIOTHIXENE THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28
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 4 · 132 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 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215456-001 THIOTHIXENE 1MG CAPSULE / ORAL AB 2022-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215456-002 THIOTHIXENE 2MG CAPSULE / ORAL AB 2022-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215456-003 THIOTHIXENE 5MG CAPSULE / ORAL AB 2022-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215456-004 THIOTHIXENE 10MG CAPSULE / ORAL AB 2022-02-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Additional Listing Data#
Finished product Yes
Brand name base thiothixene
Listing expiration 2027-12-31 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 60219-1675-1 thiothixene 100 in 1 BOTTLE, PLASTIC CAPSULE 100 10 60219-1675-7 thiothixene 1000 in 1 BOTTLE, PLASTIC CAPSULE 1000 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1675 THIOTHIXENE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] 8 Current NDC, Legacy NDC, 2 package rows 20231229_81c40311-7dc4-4332-8920-a39a8466aea6.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 · 1 matching rows.
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 60219-1675-1 60219167501 100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1675-1) 100 capsule 2022-03-03 0000-00-00 No No Current 60219-1675-7 60219167507 1000 CAPSULE in 1 BOTTLE, PLASTIC (60219-1675-7) 1000 capsule 2022-03-03 0000-00-00 No No Current