FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-655
11-digit product format
716100655
Labeler code
71610
Product ID
71610-655_e064bed4-48cf-4fac-b5f4-c62a4634984a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072928
Marketing category
ANDA
Marketing start
2021-07-20
Substance
LORAZEPAM
Active strength
2 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
LORAZEPAM2 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
71610-655-15Lorazepam15 in 1 BOTTLE, PLASTICTABLET1511
71610-655-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET3011
71610-655-45Lorazepam45 in 1 BOTTLE, PLASTICTABLET4511
71610-655-53Lorazepam60 in 1 BOTTLE, PLASTICTABLET6011
71610-655-60Lorazepam90 in 1 BOTTLE, PLASTICTABLET9011
71610-655-70Lorazepam120 in 1 BOTTLE, PLASTICTABLET12011
71610-655-80Lorazepam180 in 1 BOTTLE, PLASTICTABLET18011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-655-30EA - Each71610-65587b76e74-ac9b-4cfd-9149-ed3a5d38196b12022-10-06
71610-655-53EA - Each71610-65574d95cbe-518f-4720-9d0a-8b2f026119a012022-10-06
71610-655-60EA - Each71610-655e02e68ff-d329-456e-8ebc-adf3398bad9212022-10-06
71610-655-70EA - Each71610-6558c65974e-9472-40d8-8475-5f14dd9a4c8512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-655LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]10Current NDC, Legacy NDC, 7 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
71610-655-157161006551515 TABLET in 1 BOTTLE, PLASTIC (71610-655-15) 15 tablet2022-11-230000-00-00NoNoCurrent
71610-655-307161006553030 TABLET in 1 BOTTLE, PLASTIC (71610-655-30) 30 tablet2022-08-010000-00-00NoNoCurrent
71610-655-457161006554545 TABLET in 1 BOTTLE, PLASTIC (71610-655-45) 45 tablet2022-11-230000-00-00NoNoCurrent
71610-655-537161006555360 TABLET in 1 BOTTLE, PLASTIC (71610-655-53) 60 tablet2022-08-010000-00-00NoNoCurrent
71610-655-607161006556090 TABLET in 1 BOTTLE, PLASTIC (71610-655-60) 90 tablet2022-08-010000-00-00NoNoCurrent
71610-655-7071610065570120 TABLET in 1 BOTTLE, PLASTIC (71610-655-70) 120 tablet2022-08-010000-00-00NoNoCurrent
71610-655-8071610065580180 TABLET in 1 BOTTLE, PLASTIC (71610-655-80) 180 tablet2022-11-230000-00-00NoNoCurrent