Ativan

Product NDC
0187-0065
11-digit product format
001870065
Labeler code
0187
Product ID
0187-0065_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
2 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0187-00650187-0065-10DDiscontinued by firm2026-08-17
excluded packagepackage0187-00650187-0065-50DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050187-0065-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050187-0065-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260187-0065-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260187-0065-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310187-0065-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310187-0065-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280187-0065-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280187-0065-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210187-0065-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210187-0065-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100187-0065-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100187-0065-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310187-0065-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310187-0065-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200187-0065-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200187-0065-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100187-0065-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100187-0065-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080187-0065-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080187-0065-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030187-0065-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030187-0065-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090187-0065-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090187-0065-10557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017794-001ATIVANLORAZEPAM0.5MGTABLET / ORALABRLD, Approved before 1982
N017794-002ATIVANLORAZEPAM1MGTABLET / ORALABRLD, Approved before 1982
N017794-003ATIVANLORAZEPAM2MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017794-001AB
N017794-002AB
N017794-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-002ATIVAN1MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-003ATIVAN2MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017794-001ATIVAN0.5MGTABLET / ORALABRLD, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N017794-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017794-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017794-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017794-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017794-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017794-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017794-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017794-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017794-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017794-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017794-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017794-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017794-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017794-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017794-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017794-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017794-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017794-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017794-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017794-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017794-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017794-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Ativan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O26FZP769LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104719Internal RxNorm lookup
197900Internal RxNorm lookup
197901Internal RxNorm lookup
197902Internal RxNorm lookup
206821Internal RxNorm lookup
206828Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89057c93-8155-4040-acec-64e877bd2b4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a759f740-8682-4896-9194-8b6c103c9aeeProduct name320250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1Product name120220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285Product name220180320
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0065-01Ativan100 in 1 BOTTLETABLET10024
0187-0065-10Ativan1000 in 1 BOTTLETABLET100024
0187-0065-50Ativan500 in 1 BOTTLETABLET50024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0065-01EA - Each0187-00659761d144-5663-40c1-b490-81276929d02312014-01-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0065ATIVAN (LORAZEPAM) TABLET [BAUSCH HEALTH US LLC]20Current NDC, Legacy NDC, 3 package rows20230204_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtivanLORAZEPAMBausch Health US LLC89057c93-8155-4040-acec-64e877bd2b4c2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017794
application number: NDA017794
ndc (product): 0187-0065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206821Ativan 0.5 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
104719Ativan 1 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
206828Ativan 2 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
197900LORazepam 0.5 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
197901LORazepam 1 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
197902LORazepam 2 MG Oral TabletPSN89057c93-8155-4040-acec-64e877bd2b4c24
206821lorazepam 0.5 MG Oral Tablet [Ativan]SBD89057c93-8155-4040-acec-64e877bd2b4c24
104719lorazepam 1 MG Oral Tablet [Ativan]SBD89057c93-8155-4040-acec-64e877bd2b4c24
206828lorazepam 2 MG Oral Tablet [Ativan]SBD89057c93-8155-4040-acec-64e877bd2b4c24
197900lorazepam 0.5 MG Oral TabletSCD89057c93-8155-4040-acec-64e877bd2b4c24
197901lorazepam 1 MG Oral TabletSCD89057c93-8155-4040-acec-64e877bd2b4c24
197902lorazepam 2 MG Oral TabletSCD89057c93-8155-4040-acec-64e877bd2b4c24
206821Ativan 0.5 MG Oral TabletSY89057c93-8155-4040-acec-64e877bd2b4c24
104719Ativan 1 MG Oral TabletSY89057c93-8155-4040-acec-64e877bd2b4c24
206828Ativan 2 MG Oral TabletSY89057c93-8155-4040-acec-64e877bd2b4c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0065-0100187006501100 TABLET in 1 BOTTLE (0187-0065-01) 100 tablet2013-05-010000-00-00NoNoCurrent
0187-0065-10001870065101000 in 1 BOTTLEHistorical
0187-0065-5000187006550500 in 1 BOTTLEHistorical