Lorazepam

Product NDC
50090-5509
11-digit product format
500905509
Labeler code
50090
Product ID
50090-5509_8e489775-961e-4f82-98c5-3e5d5c5cf242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078203
Marketing category
ANDA
Marketing start
2023-05-16
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197901

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
50090-5509-02023-02-06C16284748780-1f386c649-b680-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5509-02023-01-30C16284748780-1f386c649-b680-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5509-0Lorazepam10 in 1 BOTTLETABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5509-0EA - Each50090-5509777fe344-18c7-43de-b5dc-97853e5a2c9012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5509LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20241114_be85b116-9f09-403a-8e0d-e77e344d3a9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSNbe85b116-9f09-403a-8e0d-e77e344d3a9a7
197901lorazepam 1 MG Oral TabletSCDbe85b116-9f09-403a-8e0d-e77e344d3a9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5509-05009055090010 TABLET in 1 BOTTLE (50090-5509-0) 10 tablet2023-05-160000-00-00NoNoCurrent