Home NDC 23155-890 Lurasidone Hydrochloride
Product NDC 23155-890
11-digit product format 231550890
Labeler code 23155
Product ID 23155-890_0827fe43-e438-44c3-9962-7491d04b445d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA208058
Marketing category ANDA
Marketing start 2023-10-19
Substance LURASIDONE HYDROCHLORIDE
Active strength 80 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208058-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 A208058-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 A208058-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 A208058-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 A208058-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 183 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 2026-02-19 14:30 UTC 2026-02 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208058-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208058-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208058-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208058-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208058-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-02-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 104 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lurasidone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LURASIDONE HYDROCHLORIDE 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O0P4I5851I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040031 Internal RxNorm lookup 1040041 Internal RxNorm lookup 1235247 Internal RxNorm lookup 1297278 Internal RxNorm lookup 1431235 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 23155-890-03 Lurasidone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 6 23155-890-05 Lurasidone Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 6 23155-890-09 Lurasidone Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 6 23155-890-18 Lurasidone Hydrochloride 30000 in 1 CONTAINER TABLET, FILM COATED 30000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-890 LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS INC.] 4 Current NDC, 4 package rows 20250323_083a1a52-5a13-4e28-8ef2-127ac4ce5b2d.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 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 083a1a52-5a13-4e28-8ef2-127ac4ce5b2d 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208058 application number: ANDA208058 ndc (product): 23155-890 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Golden State Medical Supply, Inc. 08ba1a4c-c193-e0ea-e063-6294a90a52dc 2025-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208058 application number: ANDA208058 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Golden State Medical Supply, Inc. 1989d512-e568-468f-e063-6294a90a5c22 2025-11-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208058 application number: ANDA208058
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 23155-890-03 23155089003 30 TABLET, FILM COATED in 1 BOTTLE (23155-890-03) 2023-10-19 No No Current 23155-890-05 23155089005 500 TABLET, FILM COATED in 1 BOTTLE (23155-890-05) 2025-08-20 No No Current 23155-890-09 23155089009 90 TABLET, FILM COATED in 1 BOTTLE (23155-890-09) 2025-08-20 No No Current 23155-890-18 23155089018 30000 TABLET, FILM COATED in 1 CONTAINER (23155-890-18) 2023-10-19 No No Current