Lorazepam

Product NDC
62135-549
11-digit product format
621350549
Labeler code
62135
Product ID
62135-549_044c464b-af13-d50f-e063-6394a90ade25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA079244
Marketing category
ANDA
Marketing start
2009-04-28
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
62135-549-43Lorazepam30 mL in 1 BOTTLECONCENTRATE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-549-43ML - Milliliter62135-5493dc91b6a-e7ca-42a2-b234-d4840a0e14f512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-549LORAZEPAM CONCENTRATE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20230902_e075c78d-f0c6-4380-b769-bb8833d23ba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311376LORazepam 2 MG in 1 mL Concentrate for Oral SolutionPSNe075c78d-f0c6-4380-b769-bb8833d23ba52
311376lorazepam 2 MG/ML Oral SolutionSCDe075c78d-f0c6-4380-b769-bb8833d23ba52
311376lorazepam 2 MG per 1 ML Concentrate for Oral SolutionSYe075c78d-f0c6-4380-b769-bb8833d23ba52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-549-436213505494330 mL in 1 BOTTLE (62135-549-43) 30 ml2023-04-20NoNoCurrent