Lorazepam

Product NDC
53002-7721
11-digit product format
530027721
Labeler code
53002
Product ID
53002-7721_d6a3eb06-5274-46f0-a4c0-8fa76ac73c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
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
53002-7721-1Lorazepam10 in 1 BOTTLETABLET105
53002-7721-2Lorazepam20 in 1 BOTTLETABLET205
53002-7721-3Lorazepam30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7721LORAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20201224_dd704e63-7162-4932-8fd1-473b3b8accca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNdd704e63-7162-4932-8fd1-473b3b8accca5
197900lorazepam 0.5 MG Oral TabletSCDdd704e63-7162-4932-8fd1-473b3b8accca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-7721-15300277210110 TABLET in 1 BOTTLE (53002-7721-1) 10 tablet2019-01-010000-00-00NoNoCurrent
53002-7721-25300277210220 TABLET in 1 BOTTLE (53002-7721-2) 20 tablet2019-01-010000-00-00NoNoCurrent
53002-7721-35300277210330 TABLET in 1 BOTTLE (53002-7721-3) 30 tablet2019-01-010000-00-00NoNoCurrent