Ativan

Product NDC: 0187-0064
Requested package NDC: 0187-0064-10
11-digit product format: 001870064
Labeler code: 0187
Product ID: 0187-0064_93bdf2de-1222-44a4-b4d5-2280f9ce58d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: Bausch Health US LLC
Application: NDA017794
Marketing category: NDA
Marketing start: 2013-05-01
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

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	0187-0064	0187-0064-10	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-0064	0187-0064-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-0064	0187-0064-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS
N017794-001	ATIVAN	LORAZEPAM	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017794-002	ATIVAN	LORAZEPAM	1MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017794-003	ATIVAN	LORAZEPAM	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017794-001	AB
N017794-002	AB
N017794-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-002	ATIVAN	1MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-003	ATIVAN	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017794-001	ATIVAN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N017794-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017794-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017794-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017794-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017794-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017794-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017794-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017794-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017794-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017794-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017794-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017794-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017794-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017794-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017794-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ativan
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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104719	Internal RxNorm lookup
197900	Internal RxNorm lookup
197901	Internal RxNorm lookup
197902	Internal RxNorm lookup
206821	Internal RxNorm lookup
206828	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
89057c93-8155-4040-acec-64e877bd2b4c	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
0187-0064-01	Ativan	100 in 1 BOTTLE	TABLET	100	24
0187-0064-10	Ativan	1000 in 1 BOTTLE	TABLET	1000	24
0187-0064-50	Ativan	500 in 1 BOTTLE	TABLET	500	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0064-01	EA - Each	0187-0064	84657a40-afa2-4da7-8f21-fc6806f3de18	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lorazepam	ACTIVE INGREDIENT	O26FZP769L	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
lorazepam	ACTIVE MOIETY	O26FZP769L	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	ATIVAN (LORAZEPAM) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-0064	ATIVAN (LORAZEPAM) TABLET [BAUSCH HEALTH US LLC]	20	Current NDC, Legacy NDC, 3 package rows	20230204_89057c93-8155-4040-acec-64e877bd2b4c.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ativan	LORAZEPAM	Bausch Health US LLC	89057c93-8155-4040-acec-64e877bd2b4c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017794 application number: NDA017794 ndc (package): 0187-0064-10 ndc (product): 0187-0064 ndc11 (package): 00187006410

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
206821	Ativan 0.5 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
104719	Ativan 1 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
206828	Ativan 2 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
197900	LORazepam 0.5 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
197901	LORazepam 1 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
197902	LORazepam 2 MG Oral Tablet	PSN	89057c93-8155-4040-acec-64e877bd2b4c	24
206821	lorazepam 0.5 MG Oral Tablet [Ativan]	SBD	89057c93-8155-4040-acec-64e877bd2b4c	24
104719	lorazepam 1 MG Oral Tablet [Ativan]	SBD	89057c93-8155-4040-acec-64e877bd2b4c	24
206828	lorazepam 2 MG Oral Tablet [Ativan]	SBD	89057c93-8155-4040-acec-64e877bd2b4c	24
197900	lorazepam 0.5 MG Oral Tablet	SCD	89057c93-8155-4040-acec-64e877bd2b4c	24
197901	lorazepam 1 MG Oral Tablet	SCD	89057c93-8155-4040-acec-64e877bd2b4c	24
197902	lorazepam 2 MG Oral Tablet	SCD	89057c93-8155-4040-acec-64e877bd2b4c	24
206821	Ativan 0.5 MG Oral Tablet	SY	89057c93-8155-4040-acec-64e877bd2b4c	24
104719	Ativan 1 MG Oral Tablet	SY	89057c93-8155-4040-acec-64e877bd2b4c	24
206828	Ativan 2 MG Oral Tablet	SY	89057c93-8155-4040-acec-64e877bd2b4c	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0064-10	00187006410	1000 TABLET in 1 BOTTLE (0187-0064-10)	1000 tablet	2013-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ativan - Bausch Health US LLC \| Bausch Health Companies Inc.	Bausch Health US LLC \| Bausch Health Companies Inc.	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	24