Lorazepam

Product NDC
0409-1539
11-digit product format
004091539
Labeler code
0409
Product ID
0409-1539_609d01a8-9c20-4e9a-a77f-527dc4487f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LORAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074243
Marketing category
ANDA
Marketing start
2005-12-28
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
4 mg/mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0409-1539DDiscontinued by firm2026-08-17
excluded packagepackage0409-15390409-1539-31DDiscontinued 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, 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 packagepackage0409-1539-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1539-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1539-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1539-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1539-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1539-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1539-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1539-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1539-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1539-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1539-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1539-31557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074243-001LORAZEPAMLORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12
A074243-002LORAZEPAMLORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074243-001AP
A074243-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074243-001LORAZEPAM2MG/MLINJECTABLE / INJECTIONAP1994-04-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074243-002LORAZEPAM4MG/MLINJECTABLE / INJECTIONAP1994-04-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 83 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074243-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A074243-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074243-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074243-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074243-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074243-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074243-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074243-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074243-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074243-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074243-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074243-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074243-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074243-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074243-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074243-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074243-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074243-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074243-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074243-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074243-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074243-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074243-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074243-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074243-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074243-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074243-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074243-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074243-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074243-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074243-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074243-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074243-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074243-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074243-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074243-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074243-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074243-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074243-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074243-002AP1bb7c543d1eb4…

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1539-03Lorazepam1 mL in 1 CARTRIDGEINJECTION, SOLUTION127
0409-1539-31Lorazepam10 in 1 CARTONINJECTION, SOLUTION1027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1539-03ML - Milliliter0409-153927d12972-f50e-4328-a38a-bf7ff8d291d712020-04-20
0409-1539-31ML - Milliliter0409-15399ce30fa5-0c2b-48b8-9e4c-494e79e6f03a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1539LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]27Legacy NDC, 2 package rows20231030_20140b19-846b-425f-b191-670e17809945.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMHospira, Inc.20140b19-846b-425f-b191-670e178099452026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074243
application number: ANDA074243
ndc (product): 0409-1539
LorazepamLORAZEPAMREMEDYREPACK INC.5a02c97d-637d-43f7-803c-afe4381ccc592026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074243
application number: ANDA074243

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763028LORazepam 2 MG in 1 ML CartridgePSN20140b19-846b-425f-b191-670e1780994527
763029LORazepam 4 MG in 1 ML CartridgePSN20140b19-846b-425f-b191-670e1780994527
7630281 ML lorazepam 2 MG/ML CartridgeSCD20140b19-846b-425f-b191-670e1780994527
7630291 ML lorazepam 4 MG/ML CartridgeSCD20140b19-846b-425f-b191-670e1780994527
763028lorazepam 2 MG per 1 ML CartridgeSY20140b19-846b-425f-b191-670e1780994527
763029lorazepam 4 MG per 1 ML CartridgeSY20140b19-846b-425f-b191-670e1780994527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1539-03004091539031 mL in 1 CARTRIDGE1 mlHistorical
0409-1539-310040915393110 CARTRIDGE in 1 CARTON (0409-1539-31) > 1 mL in 1 CARTRIDGE (0409-1539-03) 10 cartridge2005-12-280000-00-00NoNoCurrent