LORAZEPAM

Product NDC: 13107-084
11-digit product format: 131070084
Labeler code: 13107
Product ID: 13107-084_67012944-0947-4e64-adab-869993f2f709
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LORAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA203572
Marketing category: ANDA
Marketing start: 2021-02-01
Substance: LORAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203572-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203572-003	AB	1	`a50c72e98297…`

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
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 ndc (product): 13107-084
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORAZEPAM	1 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197900	Internal RxNorm lookup
197901	Internal RxNorm lookup
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
5b851f67-309d-4ef3-8b4b-ade8908256ea	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	SPL version
13107-084-01	LORAZEPAM	100 in 1 BOTTLE	TABLET	100	9
13107-084-05	LORAZEPAM	500 in 1 BOTTLE	TABLET	500	9
13107-084-10	LORAZEPAM	10 in 1 BOTTLE	TABLET	10	9
13107-084-99	LORAZEPAM	1000 in 1 BOTTLE	TABLET	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-084-01	EA - Each	13107-084	68781a71-d54c-47cb-9410-4c338d8d73bd	1	2018-07-03
13107-084-05	EA - Each	13107-084	db937882-0526-48fd-93ca-20698351ecf4	1	2018-07-03
13107-084-99	EA - Each	13107-084	f80e4ec5-9cfb-48e1-886a-93c9084d1560	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-084	LORAZEPAM TABLET [AUROLIFE PHARMA LLC]	8	Current NDC, Legacy NDC, 4 package rows	20240821_5b851f67-309d-4ef3-8b4b-ade8908256ea.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	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197901	LORazepam 1 MG Oral Tablet	PSN	11372b3d-52c0-4694-8c88-4b72d3fda9d0	9
197901	LORazepam 1 MG Oral Tablet	PSN	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197902	LORazepam 2 MG Oral Tablet	PSN	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197900	lorazepam 0.5 MG Oral Tablet	SCD	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197901	lorazepam 1 MG Oral Tablet	SCD	11372b3d-52c0-4694-8c88-4b72d3fda9d0	9
197901	lorazepam 1 MG Oral Tablet	SCD	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197902	lorazepam 2 MG Oral Tablet	SCD	5b851f67-309d-4ef3-8b4b-ade8908256ea	9
197901	LORazepam 1 MG Oral Tablet	PSN	00960fbd-a5da-408b-9867-62982f20906f	7
197901	LORazepam 1 MG Oral Tablet	PSN	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	7
197901	LORazepam 1 MG Oral Tablet	PSN	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	7
197901	lorazepam 1 MG Oral Tablet	SCD	00960fbd-a5da-408b-9867-62982f20906f	7
197901	lorazepam 1 MG Oral Tablet	SCD	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	7
197901	lorazepam 1 MG Oral Tablet	SCD	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	7
197901	LORazepam 1 MG Oral Tablet	PSN	8fa33078-c379-41f5-e053-2995a90acced	5
197901	lorazepam 1 MG Oral Tablet	SCD	8fa33078-c379-41f5-e053-2995a90acced	5
197901	LORazepam 1 MG Oral Tablet	PSN	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	4
197901	lorazepam 1 MG Oral Tablet	SCD	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	4
197901	LORazepam 1 MG Oral Tablet	PSN	823b1d71-a510-4d34-8015-60b55af23d78	3
197901	lorazepam 1 MG Oral Tablet	SCD	823b1d71-a510-4d34-8015-60b55af23d78	3
197901	LORazepam 1 MG Oral Tablet	PSN	f4c45f47-354b-6836-e053-2a95a90ac0ff	2
197901	LORazepam 1 MG Oral Tablet	PSN	247110f2-5468-4593-8d86-41f8c869e03d	2
197901	lorazepam 1 MG Oral Tablet	SCD	247110f2-5468-4593-8d86-41f8c869e03d	2
197901	lorazepam 1 MG Oral Tablet	SCD	f4c45f47-354b-6836-e053-2a95a90ac0ff	2
197900	LORazepam 0.5 MG Oral Tablet	PSN	45e31a87-a8db-4dda-b94b-83535b62e8e2	1
197901	LORazepam 1 MG Oral Tablet	PSN	2a57e549-390b-5482-e063-6394a90aeb3b	1
197901	LORazepam 1 MG Oral Tablet	PSN	8602cef8-167e-4a8c-b10f-fc3295a3abcc	1
197901	LORazepam 1 MG Oral Tablet	PSN	45e31a87-a8db-4dda-b94b-83535b62e8e2	1
197902	LORazepam 2 MG Oral Tablet	PSN	45e31a87-a8db-4dda-b94b-83535b62e8e2	1
197900	lorazepam 0.5 MG Oral Tablet	SCD	45e31a87-a8db-4dda-b94b-83535b62e8e2	1
197901	lorazepam 1 MG Oral Tablet	SCD	8602cef8-167e-4a8c-b10f-fc3295a3abcc	1
197901	lorazepam 1 MG Oral Tablet	SCD	2a57e549-390b-5482-e063-6394a90aeb3b	1
197901	lorazepam 1 MG Oral Tablet	SCD	45e31a87-a8db-4dda-b94b-83535b62e8e2	1
197902	lorazepam 2 MG Oral Tablet	SCD	45e31a87-a8db-4dda-b94b-83535b62e8e2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-084-01	13107008401	100 TABLET in 1 BOTTLE (13107-084-01)	100 tablet	2021-02-01	0000-00-00	No	No	Current
13107-084-05	13107008405	500 TABLET in 1 BOTTLE (13107-084-05)	500 tablet	2021-02-01	0000-00-00	No	No	Current
13107-084-10	13107008410	10 TABLET in 1 BOTTLE (13107-084-10)	10 tablet	2021-02-01	0000-00-00	No	No	Current
13107-084-11	13107008411	10 TABLET in 1 BOTTLE (13107-084-11)	10 tablet	2017-03-24	0000-00-00	No	No	Current
13107-084-99	13107008499	1000 TABLET in 1 BOTTLE (13107-084-99)	1000 tablet	2021-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lorazepam Tablets, USP CIV Rx only	REMEDYREPACK INC.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	8
Lorazepam Tablets USP CIV	Bryant Ranch Prepack	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	9
Lorazepam Tablets, USP CIV Rx only	Aurolife Pharma LLC \| APL HEALTHCARE LIMITED	2025-12-11	Human Prescription Drug Label	9
Lorazepam Tablets, USP CIV 8482001/0224 Rx only	American Health Packaging	2025-09-14	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam Tablets, USP CIV Rx only	Preferred Pharmaceuticals, Inc.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	7
Lorazepam Tablets USP CIV	NuCare Pharmaceuticals,Inc.	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL	4
Lorazepam Tablets, USP CIV Rx only	Advanced Rx of Tennessee, LLC	2024-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
Lorazepam Tablets USP CIV	NuCare Pharmaceuticals,Inc.	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	5
Lorazepam Tablets USP CIV	RedPharm Drug, Inc.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets USP CIV	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	7
Lorazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2024-01-21	Human Prescription Drug Label	1
Lorazepam Tablets, USP CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2023-10-17	Human Prescription Drug Label	2
Lorazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2023-08-24	Human Prescription Drug Label	3
Lorazepam Tablets USP CIV	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2