LORAZEPAM

Product NDC
61919-062
11-digit product format
619190062
Labeler code
61919
Product ID
61919-062_47e14ab4-5eb4-67c7-e063-6394a90a1e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LORAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078203
Marketing category
ANDA
Marketing start
2017-02-10
Substance
LORAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LORAZEPAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900

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
61919-062-902021-01-29C16284748780-1ba0f9c33-1dd5-a910-e053-dadaa90a0b85Lorazepam
61919-062-602020-12-14C16284748780-19d75b9cf-d259-f424-e053-dadaa90a57ceLORAZEPAM
61919-062-602020-01-31C16284748780-19d75b9cf-d259-f424-e053-dadaa90a57ceLORAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-062-02LORAZEPAM2 in 1 BOTTLETABLET25
61919-062-60LORAZEPAM60 in 1 BOTTLETABLET605
61919-062-30Lorazepam30 in 1 BOTTLETABLET304
61919-062-90Lorazepam90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-062LORAZEPAM TABLET [DIRECT RX]4Current NDC, Legacy NDC, 2 package rows20240110_4832f02d-289c-2fe6-e054-00144ff8d46c.zip
61919-062LORAZEPAM TABLET [DIRECT_RX]4Current NDC, Legacy NDC, 1 package rows20240110_8e4a2ed9-265c-1be3-e053-2995a90a4250.zip
61919-062LORAZEPAM TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190703_8cb6b6e8-66ff-46f1-e053-2a95a90a3fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN4832f02d-289c-2fe6-e054-00144ff8d46c5
197900lorazepam 0.5 MG Oral TabletSCD4832f02d-289c-2fe6-e054-00144ff8d46c5
197900LORazepam 0.5 MG Oral TabletPSN8e4a2ed9-265c-1be3-e053-2995a90a42504
197900lorazepam 0.5 MG Oral TabletSCD8e4a2ed9-265c-1be3-e053-2995a90a42504
197900LORazepam 0.5 MG Oral TabletPSN8cb6b6e8-66ff-46f1-e053-2a95a90a3fd31
197900lorazepam 0.5 MG Oral TabletSCD8cb6b6e8-66ff-46f1-e053-2a95a90a3fd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-062-02619190062022 TABLET in 1 BOTTLE (61919-062-02) 2 tablet2017-02-100000-00-00NoNoCurrent
61919-062-306191900623030 TABLET in 1 BOTTLE (61919-062-30) 30 tablet2019-07-220000-00-00NoNoCurrent
61919-062-606191900626060 TABLET in 1 BOTTLE (61919-062-60) 60 tablet2017-02-100000-00-00NoNoCurrent
61919-062-906191900629090 in 1 BOTTLEHistorical