FDA.reportPublic FDA data

Lorazepam

Product NDC
67296-2238
11-digit product format
672962238
Labeler code
67296
Product ID
67296-2238_526159d6-e0fd-992e-e063-6294a90af37c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA072927
Marketing category
ANDA
Marketing start
2021-12-09
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
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
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
67296-2238-2Lorazepam5 in 1 BOTTLE, PLASTICTABLET51
67296-2238-4Lorazepam10 in 1 BOTTLE, PLASTICTABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN52614947-c96c-3361-e063-6394a90ae1721
197901lorazepam 1 MG Oral TabletSCD52614947-c96c-3361-e063-6394a90ae1721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2238-2672962238025 TABLET in 1 BOTTLE, PLASTIC (67296-2238-2) 5 tablet2021-12-09NoNoCurrent
67296-2238-46729622380410 TABLET in 1 BOTTLE, PLASTIC (67296-2238-4) 10 tablet2022-01-11NoNoCurrent