FDA.reportPublic FDA data

Lorazepam

Product NDC
71335-1694
11-digit product format
713351694
Labeler code
71335
Product ID
71335-1694_055d96f0-cf01-4766-8627-ee66cd8a291d
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
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
71335-1694-0Lorazepam10 in 1 BOTTLETABLET109
71335-1694-1Lorazepam30 in 1 BOTTLETABLET309
71335-1694-2Lorazepam120 in 1 BOTTLETABLET1209
71335-1694-3Lorazepam15 in 1 BOTTLETABLET159
71335-1694-4Lorazepam14 in 1 BOTTLETABLET149
71335-1694-5Lorazepam90 in 1 BOTTLETABLET909
71335-1694-6Lorazepam50 in 1 BOTTLETABLET509
71335-1694-7Lorazepam60 in 1 BOTTLETABLET609
71335-1694-8Lorazepam45 in 1 BOTTLETABLET459
71335-1694-9Lorazepam100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1694-1EA - Each71335-1694185972db-16f3-4663-adde-64e014974b4b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1694LORAZEPAM TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240828_11372b3d-52c0-4694-8c88-4b72d3fda9d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN11372b3d-52c0-4694-8c88-4b72d3fda9d09
197901lorazepam 1 MG Oral TabletSCD11372b3d-52c0-4694-8c88-4b72d3fda9d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1694-07133516940010 TABLET in 1 BOTTLE (71335-1694-0) 10 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-17133516940130 TABLET in 1 BOTTLE (71335-1694-1) 30 tablet2021-03-180000-00-00NoNoCurrent
71335-1694-271335169402120 TABLET in 1 BOTTLE (71335-1694-2) 120 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-37133516940315 TABLET in 1 BOTTLE (71335-1694-3) 15 tablet2022-03-210000-00-00NoNoCurrent
71335-1694-47133516940414 TABLET in 1 BOTTLE (71335-1694-4) 14 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-57133516940590 TABLET in 1 BOTTLE (71335-1694-5) 90 tablet2021-01-290000-00-00NoNoCurrent
71335-1694-67133516940650 TABLET in 1 BOTTLE (71335-1694-6) 50 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-77133516940760 TABLET in 1 BOTTLE (71335-1694-7) 60 tablet2021-12-130000-00-00NoNoCurrent
71335-1694-87133516940845 TABLET in 1 BOTTLE (71335-1694-8) 45 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-971335169409100 TABLET in 1 BOTTLE (71335-1694-9) 100 tablet2022-09-260000-00-00NoNoCurrent