Lorazepam

Product NDC: 55289-594
Requested package NDC: 55289-594-01
11-digit product format: 552890594
Labeler code: 55289
Product ID: 55289-594_9ce4f135-398f-a169-e053-2995a90a5a8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA072928
Marketing category: ANDA
Marketing start: 1991-10-31
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55289-594	55289-594-01	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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-594-01	EA - Each	55289-594	109cb121-fd58-46ad-a0ad-e4284a176a1c	1	2012-07-24
55289-594-30	EA - Each	55289-594	9048e87b-94f5-4610-86e3-c2398694643c	1	2012-07-24
55289-594-60	EA - Each	55289-594	01e523d5-f69f-40ca-a65b-2da10276d1fa	1	2012-07-24
55289-594-90	EA - Each	55289-594	be7c6f65-f6cb-4e15-a33a-83be9037edd0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-594-01	55289059401	100 TABLET in 1 BOTTLE, PLASTIC (55289-594-01)	100 tablet	2011-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	PD-Rx Pharmaceuticals, Inc.	2020-01-24	HUMAN PRESCRIPTION DRUG LABEL	17