FDA.reportPublic FDA data

Lorazepam

Product NDC
42254-096
11-digit product format
422540096
Labeler code
42254
Product ID
42254-096_706af4a6-6595-48f9-be93-d57da75702c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078203
Marketing category
ANDA
Marketing start
2009-10-09
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

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
42254-096-202019-09-24C16284748780-19350213a-3c83-c013-e053-90daa90a1393Lorazepam Tablets, USP
42254-096-302019-09-24C16284748780-19350213a-3c83-c013-e053-90daa90a1393Lorazepam Tablets, USP
42254-096-602019-09-24C16284748780-19350213a-3c83-c013-e053-90daa90a1393Lorazepam Tablets, USP
42254-096-902019-09-24C16284748780-19350213a-3c83-c013-e053-90daa90a1393Lorazepam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-096-20Lorazepam20 in 1 BOTTLETABLET201
42254-096-30Lorazepam30 in 1 BOTTLETABLET301
42254-096-60Lorazepam60 in 1 BOTTLETABLET601
42254-096-90Lorazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-096-20EA - Each42254-096c25ae510-1d0c-4172-a74e-2494a1b6599012013-03-03
42254-096-30EA - Each42254-096f8c7ec8b-c55d-4ec1-a88e-1dab4782272a12013-03-03
42254-096-60EA - Each42254-09638e6aeb4-0678-42e3-9adc-23656af77b4612013-03-03
42254-096-90EA - Each42254-09699cac26f-8c88-4f1d-9e89-5d9612604aa612013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-096LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20130228_706af4a6-6595-48f9-be93-d57da75702c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN706af4a6-6595-48f9-be93-d57da75702c31
197901LORazepam 1 MG Oral TabletPSN706af4a6-6595-48f9-be93-d57da75702c31
197902LORazepam 2 MG Oral TabletPSN706af4a6-6595-48f9-be93-d57da75702c31
197900lorazepam 0.5 MG Oral TabletSCD706af4a6-6595-48f9-be93-d57da75702c31
197901lorazepam 1 MG Oral TabletSCD706af4a6-6595-48f9-be93-d57da75702c31
197902lorazepam 2 MG Oral TabletSCD706af4a6-6595-48f9-be93-d57da75702c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-096-204225400962020 in 1 BOTTLEHistorical
42254-096-304225400963030 in 1 BOTTLEHistorical
42254-096-604225400966060 in 1 BOTTLEHistorical
42254-096-904225400969090 in 1 BOTTLEHistorical