lurasidone hydrochloride

Product NDC: 67877-640
11-digit product format: 678770640
Labeler code: 67877
Product ID: 67877-640_6e4065a5-2672-4ef4-996d-f9d2f58970d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lurasidone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA212244
Marketing category: ANDA
Marketing start: 2023-01-04
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212244-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13
A212244-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13
A212244-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13
A212244-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13
A212244-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A212244-001	AB
A212244-002	AB
A212244-003	AB
A212244-004	AB
A212244-005	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212244-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212244-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212244-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	AB	1	`2680178bc6a6…`

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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
36b6bacd-ac11-493b-a8a4-8dad448ed9d5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2	Product name	8	20250804
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-640-05	lurasidone hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
67877-640-30	lurasidone hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
67877-640-33	lurasidone hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8
67877-640-38	lurasidone hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	8
67877-640-90	lurasidone hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-640-30	EA - Each	67877-640	6d69259e-d8ea-4b8f-9fb8-edc843e4ec4a	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-640	LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8	Current NDC, Legacy NDC, 5 package rows	20230107_36b6bacd-ac11-493b-a8a4-8dad448ed9d5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	6008ccac-948e-4b6a-a288-7dd245c2bac4	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Major Pharmaceuticals	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	American Health Packaging	b83e1015-8016-4c7c-8239-8dba3a882e46	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	c96cbfc9-773b-410a-ada3-2822cbd58f8f	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Ascend Laboratories, LLC	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	2023-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244 ndc (product): 67877-640

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O0P4I5851I	LURASIDONE HYDROCHLORIDE	367514-88-3	LURASIDONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1297278	lurasidone HCl 120 MG Oral Tablet	PSN	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1297278	lurasidone hydrochloride 120 MG Oral Tablet	SCD	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	8
1297278	lurasidone HCl 120 MG Oral Tablet	PSN	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1297278	lurasidone hydrochloride 120 MG Oral Tablet	SCD	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	5
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-640-05	67877064005	500 TABLET, FILM COATED in 1 BOTTLE (67877-640-05)		2023-01-04	0000-00-00	No	No	Current
67877-640-30	67877064030	30 TABLET, FILM COATED in 1 BOTTLE (67877-640-30)		2023-01-04	0000-00-00	No	No	Current
67877-640-33	67877064033	10 in 1 BLISTER PACK						Historical
67877-640-38	67877064038	10 BLISTER PACK in 1 CARTON (67877-640-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-640-33)	10 blister pack	2023-01-04	0000-00-00	No	No	Current
67877-640-90	67877064090	90 TABLET, FILM COATED in 1 BOTTLE (67877-640-90)		2023-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
lurasidone hydrochloride	Major Pharmaceuticals	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	5
Lurasidone Hydrochloride	American Health Packaging	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	5
lurasidone hydrochloride	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2023-01-06	Human Prescription Drug Label	8