Lorazepam

Product NDC
53002-6290
11-digit product format
530026290
Labeler code
53002
Product ID
53002-6290_41bd0cb0-71a1-426a-bc2f-1841a766f739
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
2 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
53002-6290-1Lorazepam10 in 1 BOTTLETABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6290LORAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20230609_076179cd-0974-4153-9ac6-375e51234635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN076179cd-0974-4153-9ac6-375e512346356
197902LORazepam 2 MG Oral TabletPSN076179cd-0974-4153-9ac6-375e512346356
197901lorazepam 1 MG Oral TabletSCD076179cd-0974-4153-9ac6-375e512346356
197902lorazepam 2 MG Oral TabletSCD076179cd-0974-4153-9ac6-375e512346356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-6290-15300262900110 TABLET in 1 BOTTLE (53002-6290-1) 10 tablet2017-10-010000-00-00NoNoCurrent