FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-674
11-digit product format
716100674
Labeler code
71610
Product ID
71610-674_e064bed4-48cf-4fac-b5f4-c62a4634984a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072927
Marketing category
ANDA
Marketing start
2021-12-09
Substance
LORAZEPAM
Active strength
1 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
LORAZEPAM1 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
71610-674-10Lorazepam10 in 1 BOTTLE, PLASTICTABLET1011
71610-674-15Lorazepam15 in 1 BOTTLE, PLASTICTABLET1511
71610-674-28Lorazepam28 in 1 BOTTLE, PLASTICTABLET2811
71610-674-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET3011
71610-674-45Lorazepam45 in 1 BOTTLE, PLASTICTABLET4511
71610-674-53Lorazepam60 in 1 BOTTLE, PLASTICTABLET6011
71610-674-55Lorazepam75 in 1 BOTTLE, PLASTICTABLET7511
71610-674-60Lorazepam90 in 1 BOTTLE, PLASTICTABLET9011
71610-674-70Lorazepam120 in 1 BOTTLE, PLASTICTABLET12011
71610-674-75Lorazepam150 in 1 BOTTLE, PLASTICTABLET15011
71610-674-80Lorazepam180 in 1 BOTTLE, PLASTICTABLET18011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-674-10EA - Each71610-674a76a2942-0823-4cc7-b18c-7a5d011827f812023-10-16
71610-674-15EA - Each71610-6747e6a2b9c-f44a-4812-a657-32a4dc62118f12024-01-04
71610-674-28EA - Each71610-674e6335ac0-8e45-4d83-b2fe-a5e1cc1001d212025-07-08
71610-674-45EA - Each71610-67476529a8d-cce2-4c93-ac8e-e4b50f9ed39712024-01-04
71610-674-55EA - Each71610-674b7726412-b988-4478-bdd3-2b73f54b617812024-01-04
71610-674-60EA - Each71610-674486b3936-8608-4600-b07a-be421d1b8dc112023-12-05
71610-674-70EA - Each71610-6749db3acc5-9210-4454-bfb3-dabe07e183a112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-674LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]10Current NDC, Legacy NDC, 11 package rows20250515_3c20c89f-c8c3-43b3-837e-da413f449795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197901LORazepam 1 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197902LORazepam 2 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197900lorazepam 0.5 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197901lorazepam 1 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197902lorazepam 2 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-674-107161006741010 TABLET in 1 BOTTLE, PLASTIC (71610-674-10) 10 tablet2023-07-19NoNoHistorical
71610-674-157161006741515 TABLET in 1 BOTTLE, PLASTIC (71610-674-15) 15 tablet2022-11-070000-00-00NoNoCurrent
71610-674-287161006742828 TABLET in 1 BOTTLE, PLASTIC (71610-674-28) 28 tablet2025-05-21NoNoHistorical
71610-674-307161006743030 TABLET in 1 BOTTLE, PLASTIC (71610-674-30) 30 tablet2022-11-070000-00-00NoNoCurrent
71610-674-457161006744545 TABLET in 1 BOTTLE, PLASTIC (71610-674-45) 45 tablet2022-11-070000-00-00NoNoCurrent
71610-674-537161006745360 TABLET in 1 BOTTLE, PLASTIC (71610-674-53) 60 tablet2022-11-070000-00-00NoNoCurrent
71610-674-557161006745575 TABLET in 1 BOTTLE, PLASTIC (71610-674-55) 75 tablet2022-11-070000-00-00NoNoCurrent
71610-674-607161006746090 TABLET in 1 BOTTLE, PLASTIC (71610-674-60) 90 tablet2022-11-070000-00-00NoNoCurrent
71610-674-7071610067470120 TABLET in 1 BOTTLE, PLASTIC (71610-674-70) 120 tablet2022-11-070000-00-00NoNoCurrent
71610-674-7571610067475150 TABLET in 1 BOTTLE, PLASTIC (71610-674-75) 150 tablet2022-11-070000-00-00NoNoCurrent
71610-674-8071610067480180 TABLET in 1 BOTTLE, PLASTIC (71610-674-80) 180 tablet2022-11-070000-00-00NoNoCurrent