Lorazepam

Product NDC: 0591-0242
11-digit product format: 005910242
Labeler code: 0591
Product ID: 0591-0242_a2062d88-3cf7-4da0-9cf5-d1fa5079100d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA072928
Marketing category: ANDA
Marketing start: 1991-10-31
Marketing end: 2022-11-30
Substance: LORAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0591-0242		D	Discontinued by firm	2026-08-17
excluded package	package	0591-0242	0591-0242-01	D	Discontinued by firm	2026-08-17
excluded package	package	0591-0242	0591-0242-05	D	Discontinued by firm	2026-08-17
excluded package	package	0591-0242	0591-0242-10	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 · 62 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-0242-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-0242-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-0242-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-0242-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072928-001	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB		1991-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072928-001	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 2 · 42 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	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A072928-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	AB	1	`e64feba35796…`

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
ac8efea8-f412-295f-00ce-b095e5cbc115	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0591-0242-01	2020-07-22	C162847	48780-1	ab0e2407-26c3-f274-e053-dbdaa90a6471	Lorazepam Tablets, USP C-IV
0591-0242-05	2020-07-22	C162847	48780-1	ab0e2407-26c3-f274-e053-dbdaa90a6471	Lorazepam Tablets, USP C-IV
0591-0242-10	2020-07-22	C162847	48780-1	ab0e2407-26c3-f274-e053-dbdaa90a6471	Lorazepam Tablets, USP C-IV

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-0242-01	EA - Each	0591-0242	566eba1a-ac4e-4f5c-9099-7566c5c135b9	1	2012-07-24
0591-0242-05	EA - Each	0591-0242	8ae0bbaf-c55e-4fba-8b17-c96b564cef99	1	2012-07-24
0591-0242-10	EA - Each	0591-0242	1c9a265f-d964-4eea-81ad-9aff295ab93b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	5
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [TYA PHARMACEUTICALS]	2
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [STAT RX USA LLC]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [STAT RX USA LLC]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [STAT RX USA LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [STAT RX USA LLC]	1

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	REMEDYREPACK INC.	ed37d304-04cf-43ec-a58d-d72002ff889b	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	551a1b7f-d342-2c53-e063-6394a90a9a2a	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	3c20c89f-c8c3-43b3-837e-da413f449795	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	Golden State Medical Supply, Inc.	32fb5628-bf80-0135-e063-6294a90aa3ab	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928

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
197900	LORazepam 0.5 MG Oral Tablet	PSN	0007892c-8c17-400d-b820-020aa32f433b	3
197901	LORazepam 1 MG Oral Tablet	PSN	0007892c-8c17-400d-b820-020aa32f433b	3
197902	LORazepam 2 MG Oral Tablet	PSN	0007892c-8c17-400d-b820-020aa32f433b	3
197900	lorazepam 0.5 MG Oral Tablet	SCD	0007892c-8c17-400d-b820-020aa32f433b	3
197901	lorazepam 1 MG Oral Tablet	SCD	0007892c-8c17-400d-b820-020aa32f433b	3
197902	lorazepam 2 MG Oral Tablet	SCD	0007892c-8c17-400d-b820-020aa32f433b	3
197902	LORazepam 2 MG Oral Tablet	PSN	c90ded6a-067b-4460-a456-9065ec8f7e1b	2
197902	lorazepam 2 MG Oral Tablet	SCD	c90ded6a-067b-4460-a456-9065ec8f7e1b	2
197901	LORazepam 1 MG Oral Tablet	PSN	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197902	LORazepam 2 MG Oral Tablet	PSN	d88ec7fd-89b4-48c0-98cb-e34134146540	1
197902	LORazepam 2 MG Oral Tablet	PSN	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197901	lorazepam 1 MG Oral Tablet	SCD	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197902	lorazepam 2 MG Oral Tablet	SCD	d88ec7fd-89b4-48c0-98cb-e34134146540	1
197902	lorazepam 2 MG Oral Tablet	SCD	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-0242-01	00591024201	100 TABLET in 1 BOTTLE, PLASTIC (0591-0242-01)	100 tablet	1991-10-31	2022-11-30	No	No	Current
0591-0242-05	00591024205	500 TABLET in 1 BOTTLE, PLASTIC (0591-0242-05)	500 tablet	1991-10-31	2022-11-30	No	No	Current
0591-0242-10	00591024210	1000 TABLET in 1 BOTTLE, PLASTIC (0591-0242-10)	1000 tablet	1991-10-31	2022-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV 8435501/0718 Rx only	American Health Packaging	2022-05-06	HUMAN PRESCRIPTION DRUG LABEL	8
Lorazepam Tablets, USP C-IV	Actavis Pharma, Inc.	2021-02-28	HUMAN PRESCRIPTION DRUG LABEL	22
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	REMEDYREPACK INC.	2020-11-02	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	PD-Rx Pharmaceuticals, Inc.	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	17
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	10
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	A-S Medication Solutions	2019-04-24	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam Tablets USP Revised: May 2017 Rx only CIV 220239-2	Aphena Pharma Solutions - Tennessee, LLC	2018-09-24	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets USP Revised: July 2013 Rx only CIV 220239	TYA Pharmaceuticals	2013-10-07	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets USP Revised: June 2008 Rx only CIV 173019	STAT Rx USA LLC \| PSS World Medical Inc.	2012-04-05	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-05-07	HUMAN PRESCRIPTION DRUG LABEL	3