FDA.reportPublic FDA data

Lorazepam

Product NDC
68788-7355
11-digit product format
687887355
Labeler code
68788
Product ID
68788-7355_22b4a379-4ed5-41be-be19-8df8d6a9c4af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203572
Marketing category
ANDA
Marketing start
2019-02-27
Substance
LORAZEPAM
Active strength
.5 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7355-1Lorazepam100 in 1 BOTTLETABLET1007
68788-7355-3Lorazepam30 in 1 BOTTLETABLET307
68788-7355-6Lorazepam60 in 1 BOTTLETABLET607
68788-7355-8Lorazepam120 in 1 BOTTLETABLET1207
68788-7355-9Lorazepam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7355-1EA - Each68788-7355dcc49631-8e6f-44f9-a41e-7fe75957e2f712019-05-02
68788-7355-3EA - Each68788-7355c2a0b767-d43e-41f7-887a-150cf38c0eec12019-05-02
68788-7355-6EA - Each68788-7355e3000841-b7b0-418f-9b18-ff5e791e15d912019-05-02
68788-7355-8EA - Each68788-7355cc2eae51-38e7-4fb1-afbb-d5bee45002c012019-05-02
68788-7355-9EA - Each68788-7355c0b0f829-6304-4e62-aacc-1f17670361e712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7355LORAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20240628_4a50329b-b272-4164-bddf-0d6cea3d7a23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN4a50329b-b272-4164-bddf-0d6cea3d7a238
197900lorazepam 0.5 MG Oral TabletSCD4a50329b-b272-4164-bddf-0d6cea3d7a238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7355-168788735501100 TABLET in 1 BOTTLE (68788-7355-1) 100 tablet2019-02-270000-00-00NoNoCurrent
68788-7355-36878873550330 TABLET in 1 BOTTLE (68788-7355-3) 30 tablet2019-02-270000-00-00NoNoCurrent
68788-7355-66878873550660 TABLET in 1 BOTTLE (68788-7355-6) 60 tablet2019-02-270000-00-00NoNoCurrent
68788-7355-868788735508120 TABLET in 1 BOTTLE (68788-7355-8) 120 tablet2019-02-270000-00-00NoNoCurrent
68788-7355-96878873550990 TABLET in 1 BOTTLE (68788-7355-9) 90 tablet2019-02-270000-00-00NoNoCurrent