LORAZEPAM

Product NDC: 61919-143
11-digit product format: 619190143
Labeler code: 61919
Product ID: 61919-143_343d5211-54be-7414-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LORAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: DIRECTRX
Application: ANDA078203
Marketing category: ANDA
Marketing start: 2016-06-01
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-143		U	Excluded because listing certification expired	2026-08-17
excluded package	package	61919-143	61919-143-30	U	Excluded because listing certification expired	2026-08-17
excluded package	package	61919-143	61919-143-60	U	Excluded because listing certification expired	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 · 66 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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-143-30	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-143-60	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-143-60	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-143-30	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`

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	TE codes	Approval date
A078203-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30
A078203-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30
A078203-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078203-001	AB
A078203-002	AB
A078203-003	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 · 126 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	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078203-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078203-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078203-001	AB	1	`1e350fbaab3a…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-143-30	LORAZEPAM	30 in 1 BOTTLE	TABLET	30		2
61919-143-60	LORAZEPAM	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-143-30	EA - Each	61919-143	5f50a18a-62fe-41a3-926c-315148ef5a7a	1	2016-09-02
61919-143-60	EA - Each	61919-143	f72a26cf-0725-4311-86e1-d33cda868d8e	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-143	LORAZEPAM TABLET [DIRECTRX]	2	Legacy NDC, 2 package rows	20160602_2c5ede2a-3388-04e7-e054-00144ff8d46c.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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	d6364be4-056b-4ebe-83bc-3fc85e8f488c	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	b707ecb2-644c-4323-ab0e-7bc5929cd560	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Coupler LLC	5114810c-025f-6113-e063-6294a90af538	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	1009c870-fd98-4e3b-81c8-4184036fb8c2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	A-S Medication Solutions	8361519b-be1a-4542-a782-d7cdfa153e86	2026-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	a0a33933-f697-4d3b-ba99-8a995a4b6c6b	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
LORAZEPAM	LORAZEPAM	DIRECT RX	4832f02d-289c-2fe6-e054-00144ff8d46c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	RedPharm Drug, Inc.	891b2c10-942f-0e4d-e053-2995a90af028	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	PharmPak, Inc.	b6e4d2c7-10c0-4d77-be7b-caa3d3b86997	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0681c8db-ff09-4258-a5e0-76a26b0ea0af	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Major Pharmaceuticals	62f6eb3b-813d-4890-aca9-799b7fa890df	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dd6-3746-e054-00144ff8d46c	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	503834f9-fa2e-5e23-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	A-S Medication Solutions	be85b116-9f09-403a-8e0d-e77e344d3a9a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dc1-3746-e054-00144ff8d46c	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4ab77192-8fe9-2965-e054-00144ff88e88	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	50379c41-2676-590c-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203

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	2c5ede2a-3388-04e7-e054-00144ff8d46c	2
197900	lorazepam 0.5 MG Oral Tablet	SCD	2c5ede2a-3388-04e7-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-143-30	61919014330	30 in 1 BOTTLE	Historical
61919-143-60	61919014360	60 in 1 BOTTLE	Historical