Home NDC 62332-495 Lurasidone Hydrochloride
Product NDC 62332-495
11-digit product format 623320495
Labeler code 62332
Product ID 62332-495_2ad2918d-7142-4425-bd00-45a269ef0d61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA213248
Marketing category ANDA
Marketing start 2023-01-24
Substance LURASIDONE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Atypical 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 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 A213248-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 A213248-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 A213248-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 A213248-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 A213248-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13
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 · 165 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 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213248-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213248-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213248-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213248-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213248-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2021-05-13 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 165 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lurasidone Hydrochloride
Listing expiration 2026-12-31 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 · 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 62332-495-10 Lurasidone Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 62332-495-10 Lurasidone Hydrochloride 100 in 1 CARTON TABLET, FILM COATED 100 8 62332-495-30 Lurasidone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 8 62332-495-71 Lurasidone Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 8 62332-495-90 Lurasidone Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 8 62332-495-91 Lurasidone Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-495 LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 6 package rows 20250427_1cc441b3-0a23-4c68-a90e-436030b7daf2.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Coupler LLC 4aa17493-69eb-9dc7-e063-6294a90a4c0b 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213248 application number: ANDA213248 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Coupler LLC 4742c2fd-303b-da08-e063-6294a90a7621 2025-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213248 application number: ANDA213248 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Alembic Pharmaceuticals Inc. 1cc441b3-0a23-4c68-a90e-436030b7daf2 2025-02-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213248 application number: ANDA213248 ndc (product): 62332-495 Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE Alembic Pharmaceuticals Limited 27f70e15-ee22-47ae-ba87-20e2b4a1a4d6 2023-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213248 application number: ANDA213248
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 62332-495-10 62332049510 100 BLISTER PACK in 1 CARTON (62332-495-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 100 blister pack 2023-01-24 0000-00-00 No No Current 62332-495-30 62332049530 30 TABLET, FILM COATED in 1 BOTTLE (62332-495-30) 2023-01-24 0000-00-00 No No Current 62332-495-71 62332049571 500 TABLET, FILM COATED in 1 BOTTLE (62332-495-71) 2023-01-24 0000-00-00 No No Current 62332-495-90 62332049590 90 TABLET, FILM COATED in 1 BOTTLE (62332-495-90) 2023-01-24 0000-00-00 No No Current 62332-495-91 62332049591 1000 TABLET, FILM COATED in 1 BOTTLE (62332-495-91) 2023-01-24 0000-00-00 No No Current