Home NDC 70518-4427 lurasidone hydrochloride
Product NDC 70518-4427
11-digit product format 705184427
Labeler code 70518
Product ID 70518-4427_5b265037-bc4d-467d-e063-6394a90a32f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lurasidone hydrochloride
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA208031
Marketing category ANDA
Marketing start 2025-08-06
Substance LURASIDONE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A208031-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 A208031-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 A208031-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 A208031-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 A208031-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03
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 6 · 215 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 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208031-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-01-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208031-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-01-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208031-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-01-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208031-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-01-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208031-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-01-03 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 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 hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LURASIDONE HYDROCHLORIDE 40 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4427-0 lurasidone hydrochloride 30 in 1 BLISTER PACK TABLET 30 3
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4427-0 70518442700 30 TABLET in 1 BLISTER PACK (70518-4427-0) 30 tablet 2025-08-06 No No Current