Lorazepam

Product NDC: 0641-6049
11-digit product format: 006416049
Labeler code: 0641
Product ID: 0641-6049_329ddfc8-cf47-4584-a101-4727751e1005
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA018140
Marketing category: NDA
Marketing start: 1980-07-25
Substance: LORAZEPAM
Active strength: 4 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018140-001	ATIVAN	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018140-002	ATIVAN	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018140-001	AP
N018140-002	AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018140-001	ATIVAN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018140-002	ATIVAN	4MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N018140-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018140-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018140-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018140-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018140-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018140-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018140-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018140-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018140-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018140-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018140-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018140-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018140-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018140-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018140-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018140-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018140-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018140-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018140-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018140-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018140-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018140-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018140-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018140-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018140-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018140-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018140-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018140-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018140-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	4 mg/mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238100	Internal RxNorm lookup
238101	Internal RxNorm lookup
1665188	Internal RxNorm lookup
1665326	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
4084fa74-9fd2-45ef-9d56-27bfa31d4e46	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
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
0641-6049-01	Lorazepam	1 mL in 1 VIAL	INJECTION	1		9
0641-6049-25	Lorazepam	25 in 1 CARTON	INJECTION	25		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6049-01	ML - Milliliter	0641-6049	40bb8812-10d0-4a32-8101-4b725f6aa861	1	2012-07-24
0641-6049-25	ML - Milliliter	0641-6049	1c6ef2a8-11fc-4351-ac12-c2768d144919	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6049	LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240411_4084fa74-9fd2-45ef-9d56-27bfa31d4e46.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
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140 ndc (product): 0641-6049
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	e9b54e42-04cf-4c62-90e1-36f7b31a4e81	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140
Ativan	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5fc0e987-61c9-40c4-b0d5-fcea07c8733e	2023-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	b79b38ee-c29d-4099-964f-000031f47f5a	2022-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140
Lorazepam	LORAZEPAM	Civica, Inc.	5140798d-8571-41fb-84a4-e182aac3f64c	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018140 application number: NDA018140

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
1665188	LORazepam 2 MG in 1 ML Injection	PSN	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
238100	LORazepam 2 MG/ML Injectable Solution	PSN	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
1665326	LORazepam 4 MG in 1 ML Injection	PSN	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
238101	LORazepam 4 MG/ML Injectable Solution	PSN	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
1665188	1 ML lorazepam 2 MG/ML Injection	SCD	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
1665326	1 ML lorazepam 4 MG/ML Injection	SCD	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
238100	lorazepam 2 MG/ML Injectable Solution	SCD	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
238101	lorazepam 4 MG/ML Injectable Solution	SCD	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
1665188	lorazepam 2 MG per 1 ML Injection	SY	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9
1665326	lorazepam 4 MG per 1 ML Injection	SY	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6049-01	00641604901	1 mL in 1 VIAL	1 ml					Historical
0641-6049-25	00641604925	25 VIAL in 1 CARTON (0641-6049-25) / 1 mL in 1 VIAL (0641-6049-01)	25 vial	1980-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Injection, USP	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	9