Lorazepam

Product NDC: 69315-905
11-digit product format: 693150905
Labeler code: 69315
Product ID: 69315-905_40249bb6-0d25-4b2f-aa4b-85c15af6bf8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA078203
Marketing category: ANDA
Marketing start: 2023-05-16
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

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 Identifiers#

Field, Values table
Field	Values
Unii	O26FZP769L
Rxcui	197900, 197901, 197902

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
69315-905-01	Lorazepam	100 in 1 BOTTLE	TABLET	100	13
69315-905-05	Lorazepam	500 in 1 BOTTLE	TABLET	500	13
69315-905-10	Lorazepam	1000 in 1 BOTTLE	TABLET	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-905-01	EA - Each	69315-905	cb7b39d1-65f0-4a16-ab24-2da26aed8431	1	2016-06-14
69315-905-05	EA - Each	69315-905	a5ec027b-68b4-4721-b83b-c5944599095c	1	2016-06-14
69315-905-10	EA - Each	69315-905	f28499cb-4da0-4e18-8bc2-5a003d3a5f8f	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-905	LORAZEPAM TABLET [LEADING PHARMA, LLC]	13	Current NDC, Legacy NDC, 3 package rows	20231215_5ca13415-4b77-4131-a9d2-6db26bc49167.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
197901	LORazepam 1 MG Oral Tablet	PSN	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	102
197901	lorazepam 1 MG Oral Tablet	SCD	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	102
197901	LORazepam 1 MG Oral Tablet	PSN	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	19
197901	lorazepam 1 MG Oral Tablet	SCD	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	19
197901	LORazepam 1 MG Oral Tablet	PSN	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	15
197901	lorazepam 1 MG Oral Tablet	SCD	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	15
197900	LORazepam 0.5 MG Oral Tablet	PSN	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197901	LORazepam 1 MG Oral Tablet	PSN	a0a33933-f697-4d3b-ba99-8a995a4b6c6b	13
197901	LORazepam 1 MG Oral Tablet	PSN	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197902	LORazepam 2 MG Oral Tablet	PSN	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197900	lorazepam 0.5 MG Oral Tablet	SCD	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197901	lorazepam 1 MG Oral Tablet	SCD	a0a33933-f697-4d3b-ba99-8a995a4b6c6b	13
197901	lorazepam 1 MG Oral Tablet	SCD	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197902	lorazepam 2 MG Oral Tablet	SCD	5ca13415-4b77-4131-a9d2-6db26bc49167	13
197900	LORazepam 0.5 MG Oral Tablet	PSN	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197901	LORazepam 1 MG Oral Tablet	PSN	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197902	LORazepam 2 MG Oral Tablet	PSN	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197900	lorazepam 0.5 MG Oral Tablet	SCD	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197901	lorazepam 1 MG Oral Tablet	SCD	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197902	lorazepam 2 MG Oral Tablet	SCD	62f6eb3b-813d-4890-aca9-799b7fa890df	11
197901	LORazepam 1 MG Oral Tablet	PSN	8361519b-be1a-4542-a782-d7cdfa153e86	9
197901	lorazepam 1 MG Oral Tablet	SCD	8361519b-be1a-4542-a782-d7cdfa153e86	9
197901	LORazepam 1 MG Oral Tablet	PSN	50379c41-2676-590c-e054-00144ff8d46c	7
197901	LORazepam 1 MG Oral Tablet	PSN	be85b116-9f09-403a-8e0d-e77e344d3a9a	7
197901	LORazepam 1 MG Oral Tablet	PSN	91c20f98-1c15-40ad-b721-cdd49e10bfd5	7
197901	lorazepam 1 MG Oral Tablet	SCD	be85b116-9f09-403a-8e0d-e77e344d3a9a	7
197901	lorazepam 1 MG Oral Tablet	SCD	50379c41-2676-590c-e054-00144ff8d46c	7
197901	lorazepam 1 MG Oral Tablet	SCD	91c20f98-1c15-40ad-b721-cdd49e10bfd5	7
197901	LORazepam 1 MG Oral Tablet	PSN	076179cd-0974-4153-9ac6-375e51234635	6
197901	LORazepam 1 MG Oral Tablet	PSN	973eff80-b2cd-42ca-8e88-e0151e691e59	6
197901	LORazepam 1 MG Oral Tablet	PSN	86d2cf6e-5ffc-2f68-e053-2991aa0ad403	6
197901	LORazepam 1 MG Oral Tablet	PSN	50235b15-a345-713f-e054-00144ff8d46c	6
197902	LORazepam 2 MG Oral Tablet	PSN	076179cd-0974-4153-9ac6-375e51234635	6
197901	lorazepam 1 MG Oral Tablet	SCD	86d2cf6e-5ffc-2f68-e053-2991aa0ad403	6
197901	lorazepam 1 MG Oral Tablet	SCD	076179cd-0974-4153-9ac6-375e51234635	6
197901	lorazepam 1 MG Oral Tablet	SCD	50235b15-a345-713f-e054-00144ff8d46c	6
197901	lorazepam 1 MG Oral Tablet	SCD	973eff80-b2cd-42ca-8e88-e0151e691e59	6
197902	lorazepam 2 MG Oral Tablet	SCD	076179cd-0974-4153-9ac6-375e51234635	6
197901	LORazepam 1 MG Oral Tablet	PSN	73bf2b31-5c7e-4b3a-9e97-8304931510b0	5
197901	LORazepam 1 MG Oral Tablet	PSN	503834f9-fa2e-5e23-e054-00144ff88e88	5
197901	lorazepam 1 MG Oral Tablet	SCD	73bf2b31-5c7e-4b3a-9e97-8304931510b0	5
197901	lorazepam 1 MG Oral Tablet	SCD	503834f9-fa2e-5e23-e054-00144ff88e88	5
197900	LORazepam 0.5 MG Oral Tablet	PSN	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197901	LORazepam 1 MG Oral Tablet	PSN	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197902	LORazepam 2 MG Oral Tablet	PSN	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197900	lorazepam 0.5 MG Oral Tablet	SCD	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197901	lorazepam 1 MG Oral Tablet	SCD	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197902	lorazepam 2 MG Oral Tablet	SCD	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	4
197901	LORazepam 1 MG Oral Tablet	PSN	b6e4d2c7-10c0-4d77-be7b-caa3d3b86997	3
197901	lorazepam 1 MG Oral Tablet	SCD	b6e4d2c7-10c0-4d77-be7b-caa3d3b86997	3
197901	LORazepam 1 MG Oral Tablet	PSN	117b29c3-223f-4eef-bf83-2502687a443e	2
197901	lorazepam 1 MG Oral Tablet	SCD	117b29c3-223f-4eef-bf83-2502687a443e	2
197901	LORazepam 1 MG Oral Tablet	PSN	ff98f364-eeda-4e24-a5b0-5fd42daef670	1
197901	lorazepam 1 MG Oral Tablet	SCD	ff98f364-eeda-4e24-a5b0-5fd42daef670	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-905-01	69315090501	100 TABLET in 1 BOTTLE (69315-905-01)	100 tablet	2023-05-16	0000-00-00	No	No	Current
69315-905-05	69315090505	500 TABLET in 1 BOTTLE (69315-905-05)	500 tablet	2023-05-16	0000-00-00	No	No	Current
69315-905-10	69315090510	1000 TABLET in 1 BOTTLE (69315-905-10)	1000 tablet	2023-05-16	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.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	15
Lorazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2026-01-24	HUMAN PRESCRIPTION DRUG LABEL	9
Lorazepam Tablets, USP CIV Rx only	REMEDYREPACK INC.	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	13
Lorazepam Tablets, USP CIV Rx only	REMEDYREPACK INC.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	19
Lorazepam Tablets, USP CIV Rx only	PharmPak, Inc.	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	3
Lorazepam Tablets, USP CIV Rx only	Major Pharmaceuticals	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	11
Lorazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2024-11-13	HUMAN PRESCRIPTION DRUG LABEL	7
Lorazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals, Inc.	2024-11-13	HUMAN PRESCRIPTION DRUG LABEL	5
Lorazepam - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	6
Lorazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals, Inc.	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	7
Lorazepam Tablets, USP CIV Rx only	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102
Lorazepam Tablets, USP CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2024-01-19	HUMAN PRESCRIPTION DRUG LABEL	6
Lorazepam Tablets, USP CIV Rx only	Clinical Solutions Wholesale, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	4
Lorazepam Tablets, USP CIV Rx only	Leading Pharma, LLC	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	13
LORAZEPAM	DirectRX	2023-06-23	HUMAN PRESCRIPTION DRUG LABEL	6
Lorazepam Tablets, USP CIV Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
Lorazepam Tablets, USP CIV Rx only	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
Lorazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	7
Lorazepam Tablets, USP CIV Rx only	ATLANTIC BIOLOGICALS CORP.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Lorazepam Tablets, USP CIV Rx only	Aidarex Pharmaceuticals LLC	2016-11-21	HUMAN PRESCRIPTION DRUG LABEL	1

Lorazepam

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#