LORAZEPAM

Product NDC: 72789-339
Requested package NDC: 72789-339-30
11-digit product format: 727890339
Labeler code: 72789
Product ID: 72789-339_4bbd73ca-5b7d-da52-e063-6394a90ad855
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LORAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA203572
Marketing category: ANDA
Marketing start: 2021-02-01
Substance: LORAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203572-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22
A203572-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22
A203572-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203572-001	AB
A203572-002	AB
A203572-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203572-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203572-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203572-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	REMEDYREPACK INC.	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Bryant Ranch Prepack	46af8e93-3169-408a-b4d8-b8498642801d	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals Inc.	4a50329b-b272-4164-bddf-0d6cea3d7a23	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	11372b3d-52c0-4694-8c88-4b72d3fda9d0	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	0418ad09-3069-4381-9a8f-e41b234fdac6	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (package): 72789-339-30 ndc (product): 72789-339 ndc11 (package): 72789033930
LORAZEPAM	LORAZEPAM	Aurolife Pharma LLC	5b851f67-309d-4ef3-8b4b-ade8908256ea	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	American Health Packaging	45e31a87-a8db-4dda-b94b-83535b62e8e2	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	00960fbd-a5da-408b-9867-62982f20906f	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	6cc1f35d-ff33-404e-aa5e-b01eab89863e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	DirectRx	ddcc0b2b-4be2-6d18-e053-2a95a90af987	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Advanced Rx of Tennessee, LLC	2a57e549-390b-5482-e063-6394a90aeb3b	2024-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8fa33078-c379-41f5-e053-2995a90acced	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	853c762d-0772-4f02-99ca-0bc2911f09f0	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aace309-f3ef-6aef-e053-2995a90aa197	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	933b5ef3-ec29-1a96-e053-2995a90a2d33	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	8602cef8-167e-4a8c-b10f-fc3295a3abcc	2024-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	247110f2-5468-4593-8d86-41f8c869e03d	2023-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	823b1d71-a510-4d34-8015-60b55af23d78	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572

Additional Listing Data#

Finished product: Yes
Brand name base: LORAZEPAM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O26FZP769L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197902	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0418ad09-3069-4381-9a8f-e41b234fdac6	Available on FDA.report

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
72789-339-30	LORAZEPAM	30 in 1 BOTTLE, PLASTIC	TABLET	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-339-30	EA - Each	72789-339	59027ed2-acbd-446d-9854-288b4d2a31d7	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-339	LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, 1 package rows	20241003_0418ad09-3069-4381-9a8f-e41b234fdac6.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
197902	LORazepam 2 MG Oral Tablet	PSN	0418ad09-3069-4381-9a8f-e41b234fdac6	11
197902	lorazepam 2 MG Oral Tablet	SCD	0418ad09-3069-4381-9a8f-e41b234fdac6	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-339-30	72789033930	30 TABLET in 1 BOTTLE, PLASTIC (72789-339-30)	30 tablet	2023-07-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV Rx only	PD-Rx Pharmaceuticals, Inc.	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	11