Lorazepam

Product NDC: 58118-0773
11-digit product format: 581180773
Labeler code: 58118
Product ID: 58118-0773_5b232af4-dc8b-8ee2-e063-6394a90a26ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA076045
Marketing category: ANDA
Marketing start: 2023-06-25
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
A076045-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29
A076045-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29
A076045-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076045-001	AB
A076045-002	AB
A076045-003	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	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A076045-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076045-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076045-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076045-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197901	Internal RxNorm lookup
197902	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
c0810422-b732-4c04-97d8-c1521c401ef4	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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	c0810422-b732-4c04-97d8-c1521c401ef4	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045 ndc (product): 58118-0773
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	86630bdd-13ad-4ab5-9e94-fcf2ea2113e1	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	1f79a5a1-0c40-45cf-8994-51f5ba3a5938	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	08a30230-fc95-9025-e063-6394a90ae21b	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	17919c82-87f2-5030-e063-6294a90ac91a	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1791d5c9-9004-5c4b-e063-6294a90adf3d	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	29f63525-2839-946c-e063-6294a90aebb1	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	ebdf72f7-7462-4b83-81b4-c7988860c728	2024-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1bcf608a-11c1-ec7d-e063-6394a90ab710	2024-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	0ce02d7d-d855-c73f-e063-6294a90abe93	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	SUN PHARMACEUTICAL INDUSTRIES INC	0c1caa9c-9ef1-459c-86c3-adb939130a9f	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045

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
58118-0773-8	58118077308	30 TABLET in 1 BLISTER PACK (58118-0773-8)	30 tablet	2026-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV	Clinical Solutions Wholesale, LLC	2026-09-10	HUMAN PRESCRIPTION DRUG LABEL	1