LORAZEPAM

Product NDC: 68788-4180
Requested package NDC: 68788-4180-6
11-digit product format: 687884180
Labeler code: 68788
Product ID: 68788-4180_903351ae-1bb0-4ac0-8430-df24cf2eee76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LORAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA203572
Marketing category: ANDA
Marketing start: 2026-07-31
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 · 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.

Product history page 1 of 4 · 129 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
2026-09-14 22:38:34	2026-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203572-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203572-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203572-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	AB	1	`301d65b070ca…`

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: LORAZEPAM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	1 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
197901	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
903351ae-1bb0-4ac0-8430-df24cf2eee76	Available on FDA.report

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	Preferred Pharmaceuticals Inc.	903351ae-1bb0-4ac0-8430-df24cf2eee76	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (package): 68788-4180-6 ndc (product): 68788-4180 ndc11 (package): 68788418006
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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4180-6	68788418006	60 TABLET in 1 BOTTLE (68788-4180-6)	60 tablet	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV Rx only	Preferred Pharmaceuticals Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	1