Lorazepam

Product NDC: 35356-844
11-digit product format: 353560844
Labeler code: 35356
Product ID: 35356-844_ac1dc3a6-e5f2-44bd-846f-5aff029d98f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA077657
Marketing category: ANDA
Marketing start: 2013-03-05
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-844		D	Discontinued by firm	2026-08-17
excluded package	package	35356-844	35356-844-05	D	Discontinued by firm	2026-08-17
excluded package	package	35356-844	35356-844-15	D	Discontinued by firm	2026-08-17
excluded package	package	35356-844	35356-844-30	D	Discontinued by firm	2026-08-17
excluded package	package	35356-844	35356-844-60	D	Discontinued by firm	2026-08-17
excluded package	package	35356-844	35356-844-90	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 2 · 72 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 package	package	35356-844-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-844-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-844-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-844-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-844-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-844-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-844-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-844-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-844-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-844-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-844-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-844-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-844-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-844-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-844-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-844-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-844-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-844-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-844-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-844-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-844-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-844-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-844-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-844-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-844-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-844-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-844-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-844-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-844-05	`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 package	package	35356-844-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-844-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-844-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-844-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-844-05	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A077657-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16
A077657-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16
A077657-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077657-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077657-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077657-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077657-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077657-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077657-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-844-05	EA - Each	35356-844	16e42c01-02ff-49f7-9f6e-c02a2b472e22	1	2014-01-04
35356-844-15	EA - Each	35356-844	141ad9c4-f1be-4254-bcb7-e3198ba24d4b	1	2015-10-02
35356-844-30	EA - Each	35356-844	a7e51c1b-7db7-4239-a5a6-07429ab36e73	1	2013-04-01
35356-844-60	EA - Each	35356-844	c2fdb2c1-1fae-4503-b897-42d6ab637b70	1	2013-04-01
35356-844-90	EA - Each	35356-844	a66a3de5-67de-43e4-b51e-dc9adc5c245d	1	2013-04-01