FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-654
11-digit product format
716100654
Labeler code
71610
Product ID
71610-654_e064bed4-48cf-4fac-b5f4-c62a4634984a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072926
Marketing category
ANDA
Marketing start
2021-10-11
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
71610-654-10Lorazepam10 in 1 BOTTLE, PLASTICTABLET1011
71610-654-15Lorazepam15 in 1 BOTTLE, PLASTICTABLET1511
71610-654-20Lorazepam20 in 1 BOTTLE, PLASTICTABLET2011
71610-654-28Lorazepam28 in 1 BOTTLE, PLASTICTABLET2811
71610-654-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET3011
71610-654-45Lorazepam45 in 1 BOTTLE, PLASTICTABLET4511
71610-654-53Lorazepam60 in 1 BOTTLE, PLASTICTABLET6011
71610-654-60Lorazepam90 in 1 BOTTLE, PLASTICTABLET9011
71610-654-70Lorazepam120 in 1 BOTTLE, PLASTICTABLET12011
71610-654-75Lorazepam150 in 1 BOTTLE, PLASTICTABLET15011
71610-654-80Lorazepam180 in 1 BOTTLE, PLASTICTABLET18011
71610-654-92Lorazepam270 in 1 BOTTLE, PLASTICTABLET27011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-654-10EA - Each71610-65484f6c907-afca-4aed-810b-62ed4a93d46012022-10-06
71610-654-15EA - Each71610-654415b2cf9-3905-4b61-9fb2-9b727011ba7b12022-10-06
71610-654-20EA - Each71610-654441ac9b1-7790-44d6-97ff-51b8bd9333e112022-10-06
71610-654-28EA - Each71610-654df594809-58f9-43e8-a338-b1fc4009db8b12025-06-13
71610-654-30EA - Each71610-654b8f4d534-dff5-4c91-8b20-033c100617dc12022-10-06
71610-654-45EA - Each71610-654ca5205c1-6af1-4a59-939d-b72c738a976f12022-10-06
71610-654-53EA - Each71610-6549c20d6f2-d146-480a-800e-e3ec6d0c235312022-10-06
71610-654-60EA - Each71610-6548c9a8858-7c27-48cd-8a0d-c71919ce916d12022-10-06
71610-654-70EA - Each71610-6549e27944b-1e93-464a-8ba6-d0f56ef15fc412022-10-06
71610-654-75EA - Each71610-65499498bb0-8842-4988-a195-3f9ab6a4093f12022-10-06
71610-654-80EA - Each71610-654d449ff3d-7ac8-4486-aedd-648b58d2a0a312022-10-06
71610-654-92EA - Each71610-654832bd031-5dd2-44a8-8f7f-1c497dfe214a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-654LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]10Current NDC, Legacy NDC, 12 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
71610-654-107161006541010 TABLET in 1 BOTTLE, PLASTIC (71610-654-10) 10 tablet2022-08-110000-00-00NoNoCurrent
71610-654-157161006541515 TABLET in 1 BOTTLE, PLASTIC (71610-654-15) 15 tablet2022-08-010000-00-00NoNoCurrent
71610-654-207161006542020 TABLET in 1 BOTTLE, PLASTIC (71610-654-20) 20 tablet2022-08-110000-00-00NoNoCurrent
71610-654-287161006542828 TABLET in 1 BOTTLE, PLASTIC (71610-654-28) 28 tablet2025-05-08NoNoHistorical
71610-654-307161006543030 TABLET in 1 BOTTLE, PLASTIC (71610-654-30) 30 tablet2022-08-010000-00-00NoNoCurrent
71610-654-457161006544545 TABLET in 1 BOTTLE, PLASTIC (71610-654-45) 45 tablet2022-08-010000-00-00NoNoCurrent
71610-654-537161006545360 TABLET in 1 BOTTLE, PLASTIC (71610-654-53) 60 tablet2022-08-010000-00-00NoNoCurrent
71610-654-607161006546090 TABLET in 1 BOTTLE, PLASTIC (71610-654-60) 90 tablet2022-08-010000-00-00NoNoCurrent
71610-654-7071610065470120 TABLET in 1 BOTTLE, PLASTIC (71610-654-70) 120 tablet2022-08-010000-00-00NoNoCurrent
71610-654-7571610065475150 TABLET in 1 BOTTLE, PLASTIC (71610-654-75) 150 tablet2022-08-010000-00-00NoNoCurrent
71610-654-8071610065480180 TABLET in 1 BOTTLE, PLASTIC (71610-654-80) 180 tablet2022-08-010000-00-00NoNoCurrent
71610-654-9271610065492270 TABLET in 1 BOTTLE, PLASTIC (71610-654-92) 270 tablet2022-08-110000-00-00NoNoCurrent