FDA.reportPublic FDA data

LORAZEPAM

Product NDC
72189-351
11-digit product format
721890351
Labeler code
72189
Product ID
72189-351_2c4c8caf-0897-acf6-e063-6294a90a14c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LORAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA203572
Marketing category
ANDA
Marketing start
2022-04-29
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
2026-12-31

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
72189-351-02LORAZEPAM2 in 1 BOTTLETABLET25
72189-351-30LORAZEPAM30 in 1 BOTTLETABLET305
72189-351-60LORAZEPAM60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-351-02EA - Each72189-3517dbd7795-1109-45fd-90f1-85574d41bcdb12022-06-06
72189-351-30EA - Each72189-351eb198f06-ba41-44d2-8d17-2fd5a4d0802e12022-07-06
72189-351-60EA - Each72189-351e6fdcc43-f187-4baa-878e-c0ae5f98247712022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-351LORAZEPAM TABLET [DIRECTRX]5Current NDC, Legacy NDC, 3 package rows20250123_ddcc0b2b-4be2-6d18-e053-2a95a90af987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNddcc0b2b-4be2-6d18-e053-2a95a90af9875
197900lorazepam 0.5 MG Oral TabletSCDddcc0b2b-4be2-6d18-e053-2a95a90af9875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-351-02721890351022 TABLET in 1 BOTTLE (72189-351-02) 2 tablet2022-04-290000-00-00NoNoCurrent
72189-351-307218903513030 TABLET in 1 BOTTLE (72189-351-30) 30 tablet2022-04-290000-00-00NoNoCurrent
72189-351-607218903516060 TABLET in 1 BOTTLE (72189-351-60) 60 tablet2022-04-290000-00-00NoNoCurrent