Lorazepam

Product NDC
0093-3427
11-digit product format
000933427
Labeler code
0093
Product ID
0093-3427_979c1de1-fca5-4909-9abf-a568e2a8a3de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA072928
Marketing category
ANDA
Marketing start
2021-07-20
Substance
LORAZEPAM
Active strength
2 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
LORAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900, 197901, 197902

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
0093-3427-01Lorazepam100 in 1 BOTTLE, PLASTICTABLET10012
0093-3427-05Lorazepam500 in 1 BOTTLE, PLASTICTABLET50012
0093-3427-10Lorazepam1000 in 1 BOTTLE, PLASTICTABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3427-01EA - Each0093-34274ef78235-65d8-4bb7-99e6-ed349cc73d9d12021-08-05
0093-3427-05EA - Each0093-342713ad1648-26ee-4c06-bc9a-ea2a01fb34de12021-08-05
0093-3427-10EA - Each0093-342729fef072-3b93-4a32-8426-77298f30d59c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3427LORAZEPAM TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 3 package rows20241102_1bf22e97-9425-484d-bac6-519c6bae6a37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197901LORazepam 1 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197902LORazepam 2 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197900lorazepam 0.5 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197901lorazepam 1 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197902lorazepam 2 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197900LORazepam 0.5 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197901LORazepam 1 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197902LORazepam 2 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197900lorazepam 0.5 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197901lorazepam 1 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197902lorazepam 2 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197902LORazepam 2 MG Oral TabletPSNed37d304-04cf-43ec-a58d-d72002ff889b7
197902lorazepam 2 MG Oral TabletSCDed37d304-04cf-43ec-a58d-d72002ff889b7
197900LORazepam 0.5 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197901LORazepam 1 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197902LORazepam 2 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197900lorazepam 0.5 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197901lorazepam 1 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197902lorazepam 2 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3427-0100093342701100 TABLET in 1 BOTTLE, PLASTIC (0093-3427-01) 100 tablet2021-07-200000-00-00NoNoCurrent
0093-3427-0500093342705500 TABLET in 1 BOTTLE, PLASTIC (0093-3427-05) 500 tablet2021-07-200000-00-00NoNoCurrent
0093-3427-10000933427101000 TABLET in 1 BOTTLE, PLASTIC (0093-3427-10) 1000 tablet2021-07-200000-00-00NoNoCurrent