Lorazepam

Product NDC: 0409-1985
11-digit product format: 004091985
Labeler code: 0409
Product ID: 0409-1985_e90a536c-421f-4774-8f88-013e18a8163e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LORAZEPAM
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA074243
Marketing category: ANDA
Marketing start: 2005-06-06
Substance: LORAZEPAM
Active strength: 2 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0409-1985		D	Discontinued by firm	2026-08-17
excluded product	product	0409-1985		D	Discontinued by firm	2026-08-17
excluded package	package	0409-1985	0409-1985-01	D	Discontinued by firm	2026-08-17
excluded package	package	0409-1985	0409-1985-10	D	Discontinued by firm	2026-08-17
excluded package	package	0409-1985	0409-1985-05	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-1985-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-1985-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-1985-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-1985-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-1985-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-1985-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-1985-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-1985-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-1985-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-1985-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-1985-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-1985-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-1985-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-1985-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-1985-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-1985-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-1985-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-1985-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-1985-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-1985-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-1985-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-1985-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-1985-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-1985-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-1985-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-1985-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-1985-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-1985-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-1985-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-1985-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-1985-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-1985-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-1985-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-1985-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-1985-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-1985-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074243-001	LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP		1994-04-12
A074243-002	LORAZEPAM	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP		1994-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074243-001	AP
A074243-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074243-001	LORAZEPAM	2MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074243-002	LORAZEPAM	4MG/ML	INJECTABLE / INJECTION	AP	1994-04-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 83 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	A074243-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074243-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074243-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074243-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074243-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074243-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074243-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074243-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074243-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074243-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074243-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074243-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074243-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074243-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074243-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074243-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074243-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074243-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074243-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074243-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074243-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074243-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074243-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074243-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074243-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074243-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074243-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074243-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074243-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074243-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074243-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074243-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074243-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074243-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074243-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074243-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074243-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074243-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074243-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074243-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
763028	Internal RxNorm lookup
763029	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
20140b19-846b-425f-b191-670e17809945	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
0409-1985-03	Lorazepam	1 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1		27
0409-1985-30	Lorazepam	10 in 1 CARTON	INJECTION, SOLUTION	10		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1985-03	ML - Milliliter	0409-1985	025f0ae2-3046-4f0f-882b-004d40d878f7	1	2020-04-20
0409-1985-05	ML - Milliliter	0409-1985	f6640e90-2d4b-4e4f-b275-3503af7865be	1	2012-07-24
0409-1985-10	ML - Milliliter	0409-1985	b6658d9d-ff4c-47f2-8f97-62dcc7c4c001	1	2022-06-06
0409-1985-30	ML - Milliliter	0409-1985	fd13bb17-584a-4a11-9661-5fab9ea5369f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]	11
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]	11
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]	11
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]	11
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1985	LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]	27	Current NDC, Legacy NDC, 2 package rows	20231030_20140b19-846b-425f-b191-670e17809945.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Hospira, Inc.	20140b19-846b-425f-b191-670e17809945	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074243 application number: ANDA074243 ndc (product): 0409-1985
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	5a02c97d-637d-43f7-803c-afe4381ccc59	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074243 application number: ANDA074243

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
763028	LORazepam 2 MG in 1 ML Cartridge	PSN	20140b19-846b-425f-b191-670e17809945	27
763029	LORazepam 4 MG in 1 ML Cartridge	PSN	20140b19-846b-425f-b191-670e17809945	27
763028	1 ML lorazepam 2 MG/ML Cartridge	SCD	20140b19-846b-425f-b191-670e17809945	27
763029	1 ML lorazepam 4 MG/ML Cartridge	SCD	20140b19-846b-425f-b191-670e17809945	27
763028	lorazepam 2 MG per 1 ML Cartridge	SY	20140b19-846b-425f-b191-670e17809945	27
763029	lorazepam 4 MG per 1 ML Cartridge	SY	20140b19-846b-425f-b191-670e17809945	27
763028	LORazepam 2 MG in 1 ML Cartridge	PSN	5a02c97d-637d-43f7-803c-afe4381ccc59	3
763028	1 ML lorazepam 2 MG/ML Cartridge	SCD	5a02c97d-637d-43f7-803c-afe4381ccc59	3
763028	lorazepam 2 MG per 1 ML Cartridge	SY	5a02c97d-637d-43f7-803c-afe4381ccc59	3
1665188	LORazepam 2 MG in 1 ML Injection	PSN	9f495605-0959-442c-8636-9c2d2f93bdff	1
1665188	1 ML lorazepam 2 MG/ML Injection	SCD	9f495605-0959-442c-8636-9c2d2f93bdff	1
1665188	lorazepam 2 MG per 1 ML Injection	SY	9f495605-0959-442c-8636-9c2d2f93bdff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1985-03	00409198503	1 mL in 1 CARTRIDGE	1 ml					Historical
0409-1985-30	00409198530	10 CARTRIDGE in 1 CARTON (0409-1985-30) / 1 mL in 1 CARTRIDGE (0409-1985-03)	10 cartridge	2005-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Injection, USP	REMEDYREPACK INC.	2026-08-17	HUMAN PRESCRIPTION DRUG LABEL	5
Lorazepam Injection, USP	Hospira, Inc.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	28
Lorazepam - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-18	HUMAN PRESCRIPTION DRUG LABEL	1