Lorazepam

Product NDC: 21695-238
11-digit product format: 216950238
Labeler code: 21695
Product ID: 21695-238_90d64ec4-e3af-4e78-bf7e-9d37699c98d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA071193
Marketing category: ANDA
Marketing start: 1988-04-15
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-238		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-238	21695-238-00	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-238	21695-238-15	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-238	21695-238-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-238	21695-238-60	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-238	21695-238-90	I	Inactivated by FDA	2026-10-05

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 3 · 132 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	21695-238-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-238-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-238-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-238-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-238-30	`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	21695-238-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-238-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-238-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-238-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-238-30	`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	21695-238-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-238-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-238-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-238-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-238-30	`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	21695-238-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-238-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-238-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-238-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-238-30	`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	21695-238-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-238-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-238-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-238-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-238-30	`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	21695-238-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-238-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-238-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-238-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-238-30	`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	21695-238-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-238-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-238-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-238-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-238-30	`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	21695-238-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-238-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-238-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-238-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-238-30	`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	21695-238-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-238-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-238-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-238-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-238-30	`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	21695-238-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-238-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-238-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-238-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-238-30	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071193-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL			1988-04-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071193-001	LORAZEPAM	0.5MG	TABLET / ORAL	1988-04-15	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
21695-238-00	Lorazepam Tablets, USP
21695-238-15	Lorazepam Tablets, USP
21695-238-30	Lorazepam Tablets, USP
21695-238-60	Lorazepam Tablets, USP
21695-238-90	Lorazepam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-238-00	Lorazepam	100 in 1 BOTTLE	TABLET	100	1
21695-238-15	Lorazepam	15 in 1 BOTTLE	TABLET	15	1
21695-238-30	Lorazepam	30 in 1 BOTTLE	TABLET	30	1
21695-238-60	Lorazepam	60 in 1 BOTTLE	TABLET	60	1
21695-238-90	Lorazepam	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-238-00	EA - Each	21695-238	47b98ffa-67bc-4557-a2df-89ed5770b8c5	1	2012-07-24
21695-238-15	EA - Each	21695-238	47a73de0-c1f1-43ef-a64f-fab9b9db76df	1	2012-07-24
21695-238-30	EA - Each	21695-238	d112260b-9b72-469a-9d3e-f6a82ffae364	1	2012-07-24
21695-238-60	EA - Each	21695-238	4a6266db-ecda-4cb0-b0b1-7c4c23498263	1	2012-07-24
21695-238-90	EA - Each	21695-238	0a1203b7-ba35-44f4-91c5-fad04932f1bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lorazepam	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
Lorazepam	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-238	LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 5 package rows	20110918_90d64ec4-e3af-4e78-bf7e-9d37699c98d2.zip

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	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1
197901	LORazepam 1 MG Oral Tablet	PSN	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1
197902	LORazepam 2 MG Oral Tablet	PSN	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1
197900	lorazepam 0.5 MG Oral Tablet	SCD	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1
197901	lorazepam 1 MG Oral Tablet	SCD	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1
197902	lorazepam 2 MG Oral Tablet	SCD	90d64ec4-e3af-4e78-bf7e-9d37699c98d2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-238-00	21695023800	100 in 1 BOTTLE	Historical
21695-238-15	21695023815	15 in 1 BOTTLE	Historical
21695-238-30	21695023830	30 in 1 BOTTLE	Historical
21695-238-60	21695023860	60 in 1 BOTTLE	Historical
21695-238-90	21695023890	90 in 1 BOTTLE	Historical