Home NDC 51407-832-05 Lurasidone Hydrochloride
Product NDC 51407-832
Requested package NDC 51407-832-05
11-digit product format 514070832
Labeler code 51407
Product ID 51407-832_4655e19e-554d-0a05-e063-6294a90ab7a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA208058
Marketing category ANDA
Marketing start 2019-09-04
Marketing end 2026-09-30
Substance LURASIDONE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Current FDA listing Yes 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 Active Ingredients# Ingredient, Strength table Ingredient Strength LURASIDONE HYDROCHLORIDE 40 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040031 Internal RxNorm lookup 1040041 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 51407-832-05 Lurasidone Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-832 LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Current NDC, 1 package rows 20231101_08ba1a4c-c193-e0ea-e063-6294a90a52dc.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 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 ndc (package): 51407-832-05 ndc (product): 51407-832 ndc11 (package): 51407083205 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 Marketing end Sample Exclude flag Status 51407-832-05 51407083205 500 TABLET, FILM COATED in 1 BOTTLE (51407-832-05) 2023-10-23 2026-09-30 No No Historical