Lorazepam

Product NDC: 68788-7355
11-digit product format: 687887355
Labeler code: 68788
Product ID: 68788-7355_22b4a379-4ed5-41be-be19-8df8d6a9c4af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA203572
Marketing category: ANDA
Marketing start: 2019-02-27
Substance: LORAZEPAM
Active strength: .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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203572-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22
A203572-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22
A203572-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203572-001	AB
A203572-002	AB
A203572-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203572-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	REMEDYREPACK INC.	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Bryant Ranch Prepack	46af8e93-3169-408a-b4d8-b8498642801d	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals Inc.	4a50329b-b272-4164-bddf-0d6cea3d7a23	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (product): 68788-7355
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	11372b3d-52c0-4694-8c88-4b72d3fda9d0	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0418ad09-3069-4381-9a8f-e41b234fdac6	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Aurolife Pharma LLC	5b851f67-309d-4ef3-8b4b-ade8908256ea	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	American Health Packaging	45e31a87-a8db-4dda-b94b-83535b62e8e2	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	00960fbd-a5da-408b-9867-62982f20906f	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	6cc1f35d-ff33-404e-aa5e-b01eab89863e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	DirectRx	ddcc0b2b-4be2-6d18-e053-2a95a90af987	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Advanced Rx of Tennessee, LLC	2a57e549-390b-5482-e063-6394a90aeb3b	2024-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8fa33078-c379-41f5-e053-2995a90acced	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	853c762d-0772-4f02-99ca-0bc2911f09f0	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aace309-f3ef-6aef-e053-2995a90aa197	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	933b5ef3-ec29-1a96-e053-2995a90a2d33	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	8602cef8-167e-4a8c-b10f-fc3295a3abcc	2024-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	247110f2-5468-4593-8d86-41f8c869e03d	2023-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	823b1d71-a510-4d34-8015-60b55af23d78	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572

Additional Listing Data#

Finished product: Yes
Brand name base: Lorazepam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	.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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197900	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
4a50329b-b272-4164-bddf-0d6cea3d7a23	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	SPL version
68788-7355-1	Lorazepam	100 in 1 BOTTLE	TABLET	100	7
68788-7355-3	Lorazepam	30 in 1 BOTTLE	TABLET	30	7
68788-7355-6	Lorazepam	60 in 1 BOTTLE	TABLET	60	7
68788-7355-8	Lorazepam	120 in 1 BOTTLE	TABLET	120	7
68788-7355-9	Lorazepam	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7355-1	EA - Each	68788-7355	dcc49631-8e6f-44f9-a41e-7fe75957e2f7	1	2019-05-02
68788-7355-3	EA - Each	68788-7355	c2a0b767-d43e-41f7-887a-150cf38c0eec	1	2019-05-02
68788-7355-6	EA - Each	68788-7355	e3000841-b7b0-418f-9b18-ff5e791e15d9	1	2019-05-02
68788-7355-8	EA - Each	68788-7355	cc2eae51-38e7-4fb1-afbb-d5bee45002c0	1	2019-05-02
68788-7355-9	EA - Each	68788-7355	c0b0f829-6304-4e62-aacc-1f17670361e7	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7355	LORAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 5 package rows	20240628_4a50329b-b272-4164-bddf-0d6cea3d7a23.zip

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
197900	LORazepam 0.5 MG Oral Tablet	PSN	4a50329b-b272-4164-bddf-0d6cea3d7a23	8
197900	lorazepam 0.5 MG Oral Tablet	SCD	4a50329b-b272-4164-bddf-0d6cea3d7a23	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7355-1	68788735501	100 TABLET in 1 BOTTLE (68788-7355-1)	100 tablet	2019-02-27	0000-00-00	No	No	Current
68788-7355-3	68788735503	30 TABLET in 1 BOTTLE (68788-7355-3)	30 tablet	2019-02-27	0000-00-00	No	No	Current
68788-7355-6	68788735506	60 TABLET in 1 BOTTLE (68788-7355-6)	60 tablet	2019-02-27	0000-00-00	No	No	Current
68788-7355-8	68788735508	120 TABLET in 1 BOTTLE (68788-7355-8)	120 tablet	2019-02-27	0000-00-00	No	No	Current
68788-7355-9	68788735509	90 TABLET in 1 BOTTLE (68788-7355-9)	90 tablet	2019-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV Rx only	Preferred Pharmaceuticals Inc.	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	8