FDA.reportPublic FDA data

Lorazepam

Product NDC
68788-7428
11-digit product format
687887428
Labeler code
68788
Product ID
68788-7428_22212bf6-1414-4b32-bc67-25d614c357ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
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
68788-7428-1Lorazepam100 in 1 BOTTLETABLET1007
68788-7428-3Lorazepam30 in 1 BOTTLETABLET307
68788-7428-6Lorazepam60 in 1 BOTTLETABLET607
68788-7428-8Lorazepam120 in 1 BOTTLETABLET1207
68788-7428-9Lorazepam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7428-1EA - Each68788-742892567886-e489-4cc8-a105-15d579fded7512022-03-09
68788-7428-3EA - Each68788-7428e374a0f4-480c-401d-bb58-9985d7e6ecf312022-03-09
68788-7428-6EA - Each68788-742823d5e8ab-7f20-4a93-9036-d69e799a710112022-03-09
68788-7428-8EA - Each68788-74282b8dc7cc-d4ff-4f67-bb9b-94e3c2f15a5312022-03-09
68788-7428-9EA - Each68788-7428cd12bfd6-5f65-42da-a6dd-a8ee28f9388312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7428LORAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20240628_00960fbd-a5da-408b-9867-62982f20906f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN00960fbd-a5da-408b-9867-62982f20906f7
197901lorazepam 1 MG Oral TabletSCD00960fbd-a5da-408b-9867-62982f20906f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7428-168788742801100 TABLET in 1 BOTTLE (68788-7428-1) 100 tablet2019-10-010000-00-00NoNoCurrent
68788-7428-36878874280330 TABLET in 1 BOTTLE (68788-7428-3) 30 tablet2019-10-010000-00-00NoNoCurrent
68788-7428-66878874280660 TABLET in 1 BOTTLE (68788-7428-6) 60 tablet2019-10-010000-00-00NoNoCurrent
68788-7428-868788742808120 TABLET in 1 BOTTLE (68788-7428-8) 120 tablet2019-10-010000-00-00NoNoCurrent
68788-7428-96878874280990 TABLET in 1 BOTTLE (68788-7428-9) 90 tablet2019-10-010000-00-00NoNoCurrent