Home NDC 68382-968-01 Lurasidone hydrochloride
Product NDC 68382-968
Requested package NDC 68382-968-01
11-digit product format 683820968
Labeler code 68382
Product ID 68382-968_4583ae02-09cb-4dd4-b5e7-b3074f3b95aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurasidone hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208052
Marketing category ANDA
Marketing start 2023-02-01
Substance LURASIDONE HYDROCHLORIDE
Active strength 120 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 A208052-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 A208052-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 A208052-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 A208052-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 A208052-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19
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 · 205 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 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208052-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208052-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208052-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2019-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208052-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2019-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208052-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2019-03-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 125 observed states.
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 120 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 68382-968-01 Lurasidone hydrochloride 100 in 1 BOTTLE TABLET, COATED 100 7 68382-968-05 Lurasidone hydrochloride 500 in 1 BOTTLE TABLET, COATED 500 7 68382-968-06 Lurasidone hydrochloride 30 in 1 BOTTLE TABLET, COATED 30 7 68382-968-16 Lurasidone hydrochloride 90 in 1 BOTTLE TABLET, COATED 90 7 68382-968-30 Lurasidone hydrochloride 1 in 1 BLISTER PACK TABLET, COATED 1 7 68382-968-77 Lurasidone hydrochloride 100 in 1 CARTON TABLET, COATED 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-968 LURASIDONE HYDROCHLORIDE TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.] 7 Current NDC, 6 package rows 20250323_bceb350e-4b88-4de1-9629-9629365a27a7.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68382-968-01 68382096801 100 TABLET, COATED in 1 BOTTLE (68382-968-01) 2023-02-01 No No Current