FDA.reportPublic FDA data

Lorazepam

Product NDC
62559-195
11-digit product format
625590195
Labeler code
62559
Product ID
62559-195_14501e2f-99a6-44c0-ba71-12c12d02888b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA077396
Marketing category
ANDA
Marketing start
2024-12-01
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, 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
62559-195-01Lorazepam100 in 1 BOTTLETABLET1002
62559-195-05Lorazepam500 in 1 BOTTLETABLET5002
62559-195-10Lorazepam1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-195-05EA - Each62559-1950062dd31-cbe1-400a-9d57-0f53833cbce012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-195LORAZEPAM TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20241202_787240e9-67b5-4af3-b16d-7cf314e3f2e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN787240e9-67b5-4af3-b16d-7cf314e3f2e32
197901LORazepam 1 MG Oral TabletPSN787240e9-67b5-4af3-b16d-7cf314e3f2e32
197902LORazepam 2 MG Oral TabletPSN787240e9-67b5-4af3-b16d-7cf314e3f2e32
197900lorazepam 0.5 MG Oral TabletSCD787240e9-67b5-4af3-b16d-7cf314e3f2e32
197901lorazepam 1 MG Oral TabletSCD787240e9-67b5-4af3-b16d-7cf314e3f2e32
197902lorazepam 2 MG Oral TabletSCD787240e9-67b5-4af3-b16d-7cf314e3f2e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-195-0162559019501100 TABLET in 1 BOTTLE (62559-195-01) 100 tablet2024-12-01NoNoCurrent
62559-195-0562559019505500 TABLET in 1 BOTTLE (62559-195-05) 500 tablet2024-12-01NoNoCurrent
62559-195-10625590195101000 TABLET in 1 BOTTLE (62559-195-10) 1000 tablet2024-12-01NoNoCurrent