Home NDC 13668-509 Lurasidone hydrochloride
Product NDC 13668-509
11-digit product format 136680509
Labeler code 13668
Product ID 13668-509_dba1819d-0cd5-4522-9666-5155aa9e0085
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA208047
Marketing category ANDA
Marketing start 2023-02-17
Substance LURASIDONE HYDROCHLORIDE
Active strength 60 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 42 .
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 A208047-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 A208047-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 A208047-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 A208047-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24
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 · 136 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 2026-08-18 06:07:40 2026-07 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208047-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2021-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208047-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208047-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2021-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208047-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2021-08-24 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 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 60 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 13668-509-30 Lurasidone hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-509 LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] 4 Current NDC, 1 package rows 20250418_a101e62e-dd1f-4add-8393-ba6d54adce06.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 Torrent Pharmaceuticals Limited a101e62e-dd1f-4add-8393-ba6d54adce06 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208047 application number: ANDA208047 ndc (product): 13668-509 Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE REMEDYREPACK INC. a97b59db-29e8-4b00-9d35-56b47335ee25 2025-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208047 application number: ANDA208047 Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE REMEDYREPACK INC. 672d22f6-fad5-49db-9206-f924d02af181 2025-08-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208047 application number: ANDA208047 Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE Dr. Reddys Laboratories Inc 9b512af1-98ab-1242-10e8-9534a002306e 2025-02-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208047 application number: ANDA208047
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 13668-509-30 13668050930 30 TABLET, FILM COATED in 1 BOTTLE (13668-509-30) 2023-02-17 No No Current