FDA.reportPublic FDA data

LORAZEPAM

Product NDC
50090-5562
11-digit product format
500905562
Labeler code
50090
Product ID
50090-5562_f60a5f13-501f-48b6-b13e-62160b4f343f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LORAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5562-0LORAZEPAM30 in 1 BOTTLETABLET303
50090-5562-1LORAZEPAM100 in 1 BOTTLETABLET1003
50090-5562-2LORAZEPAM60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5562-0EA - Each50090-55628f8a8200-6280-49c3-9959-52a3b4bb5ffb12023-09-05
50090-5562-1EA - Each50090-556236dd90b1-f714-4cd1-b517-7b3455bb1c2912023-09-05
50090-5562-2EA - Each50090-55626097c6ec-beeb-4cad-8262-b9f6d9df512b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5562LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20230825_823b1d71-a510-4d34-8015-60b55af23d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN823b1d71-a510-4d34-8015-60b55af23d783
197901lorazepam 1 MG Oral TabletSCD823b1d71-a510-4d34-8015-60b55af23d783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5562-05009055620030 TABLET in 1 BOTTLE (50090-5562-0) 30 tablet2023-08-23NoNoCurrent
50090-5562-150090556201100 TABLET in 1 BOTTLE (50090-5562-1) 100 tablet2021-06-18NoNoCurrent
50090-5562-25009055620260 TABLET in 1 BOTTLE (50090-5562-2) 60 tablet2021-06-18NoNoCurrent