Lorazepam

Product NDC
65162-687
11-digit product format
651620687
Labeler code
65162
Product ID
65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA091383
Marketing category
ANDA
Marketing start
2010-02-01
Substance
LORAZEPAM
Active strength
2 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui311376

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
65162-687-84Lorazepam30 mL in 1 BOTTLE, DROPPERCONCENTRATE3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-687LORAZEPAM CONCENTRATE [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 1 package rows20241030_bf265c2e-ab2f-42e5-96cf-3998eb5a644d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311376LORazepam 2 MG in 1 mL Concentrate for Oral SolutionPSNbf265c2e-ab2f-42e5-96cf-3998eb5a644d18
311376lorazepam 2 MG/ML Oral SolutionSCDbf265c2e-ab2f-42e5-96cf-3998eb5a644d18
311376lorazepam 2 MG per 1 ML Concentrate for Oral SolutionSYbf265c2e-ab2f-42e5-96cf-3998eb5a644d18
311376LORazepam 2 MG in 1 mL Concentrate for Oral SolutionPSN093a6f7b-1ea8-4467-bd0f-5f7d29067d321
311376lorazepam 2 MG/ML Oral SolutionSCD093a6f7b-1ea8-4467-bd0f-5f7d29067d321
311376lorazepam 2 MG per 1 ML Concentrate for Oral SolutionSY093a6f7b-1ea8-4467-bd0f-5f7d29067d321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-687-846516206878430 mL in 1 BOTTLE, DROPPER (65162-687-84) 30 ml2010-02-010000-00-00NoNoCurrent