Home NDC 72189-598 Lurasidone HCL
Product NDC 72189-598
11-digit product format 721890598
Labeler code 72189
Product ID 72189-598_296811cf-cba9-16c2-e063-6294a90acfa6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone HCL
Dosage form TABLET
Route ORAL
Labeler Direct_rx
Application ANDA208045
Marketing category ANDA
Marketing start 2024-12-16
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 43 .
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 A208045-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 A208045-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 A208045-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 A208045-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 A208045-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10
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 4 · 125 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 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208045-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208045-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208045-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208045-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2023-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208045-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2023-03-10 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 125 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lurasidone HCL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040031 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 72189-598-30 Lurasidone HCL 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-598 LURASIDONE HCL TABLET [DIRECT_RX] 1 Current NDC, 1 package rows 20241219_296811cf-cba8-16c2-e063-6294a90acfa6.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 Aurobindo Pharma Limited b3e9cc86-0c5c-444f-ab57-f4d1a6865035 2026-06-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208045 application number: ANDA208045 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE Coupler LLC 4973beed-b75b-c370-e063-6394a90a26e5 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208045 application number: ANDA208045 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE Proficient Rx LP fa9f0d28-c525-4a1e-acec-84c82e10b9a2 2025-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208045 application number: ANDA208045 Lurasidone HCL LURASIDONE HCL Direct_rx 296811cf-cba8-16c2-e063-6294a90acfa6 2024-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208045 application number: ANDA208045 ndc (product): 72189-598
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-598-30 72189059830 30 TABLET in 1 BOTTLE (72189-598-30) 30 tablet 2024-12-16 No No Current