Lorazepam

Product NDC
75921-241
11-digit product format
759210241
Labeler code
75921
Product ID
75921-241_11adb6a6-f550-4c38-96c4-4092bc84d956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Life Line Home Care Services, Inc.
Application
ANDA072927
Marketing category
ANDA
Marketing start
1991-10-31
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 productproduct75921-241IInactivated by FDA2026-10-05
excluded packagepackage75921-24175921-241-30IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75921-241-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75921-241-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75921-241-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75921-241-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75921-241-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75921-241-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75921-241-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75921-241-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75921-241-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75921-241-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75921-241-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75921-241-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75921-241-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75921-241-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75921-241-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75921-241-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75921-241-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75921-241-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75921-241-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75921-241-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75921-241-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75921-241-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072927-001LORAZEPAMLORAZEPAM1MGTABLET / ORALAB1991-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072927-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3184e616aacf4f…
2026-08-18 06:07:402026-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A072927-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A072927-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072927-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072927-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072927-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072927-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072927-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072927-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072927-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072927-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072927-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072927-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072927-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072927-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072927-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072927-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072927-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072927-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072927-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072927-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072927-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072927-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072927-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072927-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072927-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072927-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072927-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072927-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072927-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072927-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072927-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072927-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072927-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072927-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072927-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072927-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072927-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072927-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072927-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072927-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75921-241-302019-11-13C16284748780-197449f38-be61-f6ea-e053-dbdaa90aa703Lorazepam Tablets USP Revised: June 2008 Rx only CIV 173019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-241-30Lorazepam30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-241LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1Legacy NDC, 1 package rows20120216_463faf3c-3a5b-42a5-92bb-b1299ca29682.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMCoupler LLC54d72943-f8d1-5a78-e063-6294a90a059b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMRedpharm Drug52614947-c96c-3361-e063-6394a90ae1722026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7afd9a59-3463-4eda-8cf3-ef90be05de3d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC3c20c89f-c8c3-43b3-837e-da413f4497952025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMGolden State Medical Supply, Inc.32fb5628-bf80-0135-e063-6294a90aa3ab2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMTeva Pharmaceuticals USA, Inc.1bf22e97-9425-484d-bac6-519c6bae6a372023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN463faf3c-3a5b-42a5-92bb-b1299ca296821
197901lorazepam 1 MG Oral TabletSCD463faf3c-3a5b-42a5-92bb-b1299ca296821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-241-307592102413030 in 1 BOTTLEHistorical