LOREEV XR

Product NDC: 50090-7592
11-digit product format: 500907592
Labeler code: 50090
Product ID: 50090-7592_797bc295-d908-4740-b496-c87e19b0eca4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lorazepam
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA214826
Marketing category: NDA
Marketing start: 2022-03-01
Substance: LORAZEPAM
Active strength: 1.5 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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	RLD / RS	Approval date
N214826-001	LOREEV XR	LORAZEPAM	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27
N214826-002	LOREEV XR	LORAZEPAM	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27
N214826-003	LOREEV XR	LORAZEPAM	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27
N214826-004	LOREEV XR	LORAZEPAM	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22
N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21

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 · 134 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-001	LOREEV XR	1MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-002	LOREEV XR	2MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-003	LOREEV XR	3MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-004	LOREEV XR	1.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2022-02-16	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-001	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-002	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-003	8999393	2034-01-08	U-3210	Drug product	2021-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214826-004	8999393	2034-01-08	U-3210	Drug product	2022-04-21	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: LOREEV XR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O26FZP769L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2594600	Internal RxNorm lookup
2594603	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
c470fdee-8e18-4da9-b072-943d6b2518cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a759f740-8682-4896-9194-8b6c103c9aee	Product name	3	20250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1	Product name	1	20220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285	Product name	2	20180320
ac8efea8-f412-295f-00ce-b095e5cbc115	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7592-0	LOREEV XR	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7592-0	EA - Each	50090-7592	e5602a24-f4d9-450c-a460-b710099084ab	1	2025-08-11

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOREEV XR	LORAZEPAM	Almatica Pharma LLC	227734c1-bf01-9607-73ea-5a1f38a89bd9	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214826 application number: NDA214826
LOREEV XR	LORAZEPAM	A-S Medication Solutions	c470fdee-8e18-4da9-b072-943d6b2518cf	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214826 application number: NDA214826 ndc (product): 50090-7592

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O26FZP769L	LORAZEPAM	846-49-1	LORAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2594600	LORazepam 1.5 MG 24HR Extended Release Oral Capsule	PSN	c470fdee-8e18-4da9-b072-943d6b2518cf	1
2594603	Loreev XR 1.5 MG 24HR Extended Release Oral Capsule	PSN	c470fdee-8e18-4da9-b072-943d6b2518cf	1
2594603	24 HR lorazepam 1.5 MG Extended Release Oral Capsule [Loreev]	SBD	c470fdee-8e18-4da9-b072-943d6b2518cf	1
2594600	24 HR lorazepam 1.5 MG Extended Release Oral Capsule	SCD	c470fdee-8e18-4da9-b072-943d6b2518cf	1
2594603	24 HR Loreev 1.5 MG Extended Release Oral Capsule	SY	c470fdee-8e18-4da9-b072-943d6b2518cf	1
2594603	Loreev XR 1.5 MG 24 HR Extended Release Oral Capsule	SY	c470fdee-8e18-4da9-b072-943d6b2518cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7592-0	50090759200	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-7592-0)	2025-07-02	No	No	Current