Lorazepam

Product NDC: 0591-0241
Requested package NDC: 0591-0241-01
11-digit product format: 005910241
Labeler code: 0591
Product ID: 0591-0241_a2062d88-3cf7-4da0-9cf5-d1fa5079100d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA072927
Marketing category: ANDA
Marketing start: 1991-10-31
Marketing end: 2023-04-30
Substance: LORAZEPAM
Active strength: 1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0591-0241	0591-0241-01	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
A072927-001	LORAZEPAM	LORAZEPAM	1MG	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
A072927-001	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	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072927-001	LORAZEPAM	1MG	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	A072927-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072927-001	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
0591-0241-01	2020-07-22	C162847	48780-1	ab0e2407-26c3-f274-e053-dbdaa90a6471	Lorazepam Tablets, USP C-IV
0591-0241-05	2020-07-22	C162847	48780-1	ab0e2407-26c3-f274-e053-dbdaa90a6471	Lorazepam Tablets, USP C-IV
0591-0241-10	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
0591-0241-01	EA - Each	0591-0241	0c1de111-7094-4b61-90d9-90b38eb7d348	1	2012-07-24
0591-0241-05	EA - Each	0591-0241	33c214fa-3123-429f-8ce1-c63d61f6756c	1	2012-07-24
0591-0241-10	EA - Each	0591-0241	8d627f5b-78af-418c-b914-d5ff923e70d3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [BRYANT RANCH PREPACK]	1002
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]	8
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	8
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	6
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [STAT RX USA LLC]	4
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [STAT RX USA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [STAT RX USA LLC]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [STAT RX USA LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [STAT RX USA LLC]	4
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [STAT RX USA LLC]	4
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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]	2
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [NORTHWIND PHARMACEUTICALS]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [STAT RX USA LLC]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [REDPHARM DRUG INC.]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LORAZEPAM	ACTIVE MOIETY	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 [REDPHARM DRUG INC.]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [NORTHWIND PHARMACEUTICALS]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [REDPHARM DRUG INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [REDPHARM DRUG INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LORAZEPAM TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	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 [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [STAT RX USA LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [REDPHARM DRUG INC.]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, 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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	6c5356b1-c199-49ad-bb00-fd67c6691f74	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Coupler LLC	54d72943-f8d1-5a78-e063-6294a90a059b	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Redpharm Drug	52614947-c96c-3361-e063-6394a90ae172	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7afd9a59-3463-4eda-8cf3-ef90be05de3d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
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): 072927 application number: ANDA072927
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): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927

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
197901	LORazepam 1 MG Oral Tablet	PSN	469c9815-5139-498d-b2ba-915056c0b1b0	24
197901	lorazepam 1 MG Oral Tablet	SCD	469c9815-5139-498d-b2ba-915056c0b1b0	24
197900	LORazepam 0.5 MG Oral Tablet	PSN	84e74f60-4e4f-412f-a3ff-f3252838f371	4
197901	LORazepam 1 MG Oral Tablet	PSN	84e74f60-4e4f-412f-a3ff-f3252838f371	4
197900	lorazepam 0.5 MG Oral Tablet	SCD	84e74f60-4e4f-412f-a3ff-f3252838f371	4
197901	lorazepam 1 MG Oral Tablet	SCD	84e74f60-4e4f-412f-a3ff-f3252838f371	4
197900	LORazepam 0.5 MG Oral Tablet	PSN	0007892c-8c17-400d-b820-020aa32f433b	3
197901	LORazepam 1 MG Oral Tablet	PSN	2c4635eb-3e71-4ef4-b151-2ced67a7ead2	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	2c4635eb-3e71-4ef4-b151-2ced67a7ead2	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
197901	LORazepam 1 MG Oral Tablet	PSN	119415c4-86cc-1626-e054-00144ff8d46c	2
197901	LORazepam 1 MG Oral Tablet	PSN	266e755e-a355-4cb8-af7b-5a77693db6dc	2
197901	lorazepam 1 MG Oral Tablet	SCD	119415c4-86cc-1626-e054-00144ff8d46c	2
197901	lorazepam 1 MG Oral Tablet	SCD	266e755e-a355-4cb8-af7b-5a77693db6dc	2
197901	LORazepam 1 MG Oral Tablet	PSN	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197901	LORazepam 1 MG Oral Tablet	PSN	463faf3c-3a5b-42a5-92bb-b1299ca29682	1
197901	LORazepam 1 MG Oral Tablet	PSN	3af556f7-3d8c-4079-b6bc-5051966e5f3b	1
197901	LORazepam 1 MG Oral Tablet	PSN	2023747b-5775-4a7f-bc52-9ecd458fc9c1	1
197902	LORazepam 2 MG Oral Tablet	PSN	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197901	lorazepam 1 MG Oral Tablet	SCD	463faf3c-3a5b-42a5-92bb-b1299ca29682	1
197901	lorazepam 1 MG Oral Tablet	SCD	3af556f7-3d8c-4079-b6bc-5051966e5f3b	1
197901	lorazepam 1 MG Oral Tablet	SCD	e9f1608a-1d75-4cd0-b156-795f79c1b4de	1
197901	lorazepam 1 MG Oral Tablet	SCD	2023747b-5775-4a7f-bc52-9ecd458fc9c1	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
0591-0241-01	00591024101	100 TABLET in 1 BOTTLE, PLASTIC (0591-0241-01)	100 tablet	1991-10-31	2023-03-31	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	PD-Rx Pharmaceuticals, Inc.	2022-04-29	HUMAN PRESCRIPTION DRUG LABEL	21
Lorazepam Tablets, USP C-IV	PD-Rx Pharmaceuticals, Inc.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	19
Lorazepam Tablets, USP C-IV	REMEDYREPACK INC.	2021-07-14	HUMAN PRESCRIPTION DRUG LABEL	4
Lorazepam Tablets, USP C-IV	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	24
Lorazepam Tablets, USP C-IV	A-S Medication Solutions	2021-06-10	HUMAN PRESCRIPTION DRUG LABEL	37
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	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceutuicals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	RPK Pharmaceuticals, Inc.	2020-12-16	HUMAN PRESCRIPTION DRUG LABEL	3
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	REMEDYREPACK INC.	2019-09-18	HUMAN PRESCRIPTION DRUG LABEL	3
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	2019-04-25	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	A-S Medication Solutions	2019-01-03	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets, USP Revised: May 2017 Rx only C-IV 220239-2	Bryant Ranch Prepack	2018-12-23	HUMAN PRESCRIPTION DRUG LABEL	1006
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: October 2014 Rx only CIV 220239-1	Blenheim Pharmacal, Inc.	2015-03-18	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam - Northwind Pharmaceuticals \| EPM Packaging	Northwind Pharmaceuticals \| EPM Packaging	2014-06-19	HUMAN PRESCRIPTION DRUG LABEL	1
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 Tablets USP Revised: June 2008 Rx only CIV 173019	Life Line Home Care Services, Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	1
LORAZEPAM tablet	RedPharm Drug Inc. \| Watson Laboratories, Inc.	2011-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam Tablet	STAT RX USA LLC	2010-12-17	HUMAN PRESCRIPTION DRUG LABEL	4
Lorazepam - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-05-07	HUMAN PRESCRIPTION DRUG LABEL	3