FDA.reportPublic FDA data

Lorazepam

Product NDC
50090-0273
11-digit product format
500900273
Labeler code
50090
Product ID
50090-0273_105bd1dc-8a5f-47bf-b4a4-950363c0b44d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0273-02023-01-30C16284748780-1f386c649-e2de-0266-e053-dadaa90a7c1aLorazepam Tablets, USP C-IV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0273-0Lorazepam10 in 1 BOTTLE, PLASTICTABLET1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0273-0EA - Each50090-0273bd43de5f-9c78-4e5e-bfab-586bb50c4b7912018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0273LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS]24Legacy NDC, 1 package rows20210615_469c9815-5139-498d-b2ba-915056c0b1b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN469c9815-5139-498d-b2ba-915056c0b1b024
197901lorazepam 1 MG Oral TabletSCD469c9815-5139-498d-b2ba-915056c0b1b024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0273-05009002730010 TABLET in 1 BOTTLE, PLASTIC (50090-0273-0) 10 tablet2014-11-280000-00-00NoNoCurrent