Lorazepam

Product NDC
53002-5290
11-digit product format
530025290
Labeler code
53002
Product ID
53002-5290_8b4f2428-a340-43f9-9213-3cf620477e20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, 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
No
Listing certified through
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5290-1Lorazepam10 in 1 BOTTLETABLET103
53002-5290-2Lorazepam20 in 1 BOTTLETABLET203
53002-5290-3Lorazepam30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5290LORAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20201218_2c4635eb-3e71-4ef4-b151-2ced67a7ead2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN2c4635eb-3e71-4ef4-b151-2ced67a7ead23
197901lorazepam 1 MG Oral TabletSCD2c4635eb-3e71-4ef4-b151-2ced67a7ead23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5290-15300252900110 TABLET in 1 BOTTLE (53002-5290-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-5290-25300252900220 TABLET in 1 BOTTLE (53002-5290-2) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-5290-35300252900330 TABLET in 1 BOTTLE (53002-5290-3) 30 tablet2017-10-010000-00-00NoNoCurrent