Lorazepam

Product NDC: 70166-260
11-digit product format: 701660260
Labeler code: 70166
Product ID: 70166-260_968adf23-7662-77a3-e053-2995a90aa62b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: CONCENTRATE
Route: ORAL
Labeler: Lohxa
Application: ANDA091383
Marketing category: ANDA
Marketing start: 2010-02-01
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 2 mg/mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70166-260		I	Inactivated by FDA	2026-08-17
excluded package	package	70166-260	70166-260-03	I	Inactivated by FDA	2026-08-17
excluded package	package	70166-260	70166-260-05	I	Inactivated by FDA	2026-08-17
excluded package	package	70166-260	70166-260-06	I	Inactivated by FDA	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 · 76 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	70166-260-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-260-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-260-06	`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	70166-260-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-260-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-260-06	`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	70166-260-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-260-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-260-06	`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	70166-260-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-260-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-260-06	`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	70166-260-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-260-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-260-06	`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	70166-260-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-260-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-260-06	`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	70166-260-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-260-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-260-06	`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	70166-260-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-260-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-260-06	`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	70166-260-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-260-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-260-06	`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	70166-260-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-260-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-260-06	`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 package	package	70166-260-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70166-260-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70166-260-06	`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 package	package	70166-260-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70166-260-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70166-260-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70166-260-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70166-260-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70166-260-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70166-260-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70166-260-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70166-260-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70166-260-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70166-260-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70166-260-06	`1332a3947898…`	`d4bfe170f9cd…`

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
A091383-001	LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA		2009-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091383-001	AA

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	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091383-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2009-12-23	`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	A091383-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091383-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091383-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091383-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091383-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091383-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091383-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091383-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091383-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091383-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091383-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091383-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091383-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091383-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091383-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091383-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091383-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091383-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091383-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091383-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091383-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091383-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091383-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091383-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091383-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091383-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091383-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091383-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091383-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091383-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091383-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091383-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091383-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091383-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091383-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091383-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091383-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091383-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091383-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091383-001	AA	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
70166-260-03	2021-01-29	C162847	48780-1	ba0f9c33-2a13-a910-e053-dadaa90a0b85	Lorazepam Oral Concentrate USP, 2 mg per mL, CIV
70166-260-05	2021-01-29	C162847	48780-1	ba0f9c33-2a13-a910-e053-dadaa90a0b85	Lorazepam Oral Concentrate USP, 2 mg per mL, CIV
70166-260-06	2021-01-29	C162847	48780-1	ba0f9c33-2a13-a910-e053-dadaa90a0b85	Lorazepam Oral Concentrate USP, 2 mg per mL, CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70166-260-03	Lorazepam	0.5 mL in 1 SYRINGE, PLASTIC	CONCENTRATE	0.5	1
70166-260-03	Lorazepam	30 in 1 PACKAGE	CONCENTRATE	30	1
70166-260-05	Lorazepam	1 mL in 1 SYRINGE, PLASTIC	CONCENTRATE	1	1
70166-260-05	Lorazepam	30 in 1 PACKAGE	CONCENTRATE	30	1
70166-260-06	Lorazepam	60 in 1 PACKAGE	CONCENTRATE	60	1
70166-260-06	Lorazepam	0.5 mL in 1 SYRINGE, PLASTIC	CONCENTRATE	0.5	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70166-260-03	EA - Each	70166-260	1668b46b-b86c-495c-b09f-a0606a980b13	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-260	LORAZEPAM CONCENTRATE [LOHXA]	1	Legacy NDC, 6 package rows	20191105_093a6f7b-1ea8-4467-bd0f-5f7d29067d32.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Amneal Pharmaceuticals LLC	bf265c2e-ab2f-42e5-96cf-3998eb5a644d	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091383 application number: ANDA091383

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
311376	LORazepam 2 MG in 1 mL Concentrate for Oral Solution	PSN	093a6f7b-1ea8-4467-bd0f-5f7d29067d32	1
311376	lorazepam 2 MG/ML Oral Solution	SCD	093a6f7b-1ea8-4467-bd0f-5f7d29067d32	1
311376	lorazepam 2 MG per 1 ML Concentrate for Oral Solution	SY	093a6f7b-1ea8-4467-bd0f-5f7d29067d32	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
70166-260-03	70166026003	0.5 mL in 1 SYRINGE, PLASTIC	0.5 ml	Historical
70166-260-05	70166026005	1 mL in 1 SYRINGE, PLASTIC	1 ml	Historical
70166-260-06	70166026006	60 in 1 PACKAGE		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Oral Concentrate USP, 2 mg per mL, CIV	Lohxa	2019-11-04	HUMAN PRESCRIPTION DRUG LABEL	1