FDA.reportPublic FDA data

Lorazepam

Product NDC
71335-1455
11-digit product format
713351455
Labeler code
71335
Product ID
71335-1455_b8091a41-9d1a-4faa-849b-583d24a5772d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
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
71335-1455-1Lorazepam30 in 1 BOTTLETABLET30103
71335-1455-2Lorazepam10 in 1 BOTTLETABLET10103
71335-1455-3Lorazepam60 in 1 BOTTLETABLET60103
71335-1455-4Lorazepam90 in 1 BOTTLETABLET90103
71335-1455-5Lorazepam15 in 1 BOTTLETABLET15103
71335-1455-6Lorazepam100 in 1 BOTTLETABLET100103
71335-1455-7Lorazepam120 in 1 BOTTLETABLET120103
71335-1455-8Lorazepam2 in 1 BOTTLETABLET2103
71335-1455-9Lorazepam5 in 1 BOTTLETABLET5103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1455-3EA - Each71335-14550366fd6b-2526-4bfa-a4d9-9bc49e828c3012022-10-06
71335-1455-4EA - Each71335-145516fa3d9a-8f30-4615-ab9e-90cc61fdf28912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1455LORAZEPAM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20240828_853c762d-0772-4f02-99ca-0bc2911f09f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN853c762d-0772-4f02-99ca-0bc2911f09f0103
197900lorazepam 0.5 MG Oral TabletSCD853c762d-0772-4f02-99ca-0bc2911f09f0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1455-17133514550130 TABLET in 1 BOTTLE (71335-1455-1) 30 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-27133514550210 TABLET in 1 BOTTLE (71335-1455-2) 10 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-37133514550360 TABLET in 1 BOTTLE (71335-1455-3) 60 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-47133514550490 TABLET in 1 BOTTLE (71335-1455-4) 90 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-57133514550515 TABLET in 1 BOTTLE (71335-1455-5) 15 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-671335145506100 TABLET in 1 BOTTLE (71335-1455-6) 100 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-771335145507120 TABLET in 1 BOTTLE (71335-1455-7) 120 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-8713351455082 TABLET in 1 BOTTLE (71335-1455-8) 2 tablet2022-05-040000-00-00NoNoCurrent
71335-1455-9713351455095 TABLET in 1 BOTTLE (71335-1455-9) 5 tablet2022-05-040000-00-00NoNoCurrent