FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-178
11-digit product format
716100178
Labeler code
71610
Product ID
71610-178_8328a536-b498-4fcb-8a49-19d79fa25f29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
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
Rxcui197902

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
71610-178-15Lorazepam15 in 1 BOTTLETABLET151
71610-178-30Lorazepam30 in 1 BOTTLETABLET301
71610-178-45Lorazepam45 in 1 BOTTLETABLET451
71610-178-53Lorazepam60 in 1 BOTTLETABLET601
71610-178-60Lorazepam90 in 1 BOTTLETABLET901
71610-178-70Lorazepam120 in 1 BOTTLETABLET1201
71610-178-80Lorazepam180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-178-15EA - Each71610-1782a6e1d08-b79f-4764-91b0-e9eb0681a31112019-01-24
71610-178-30EA - Each71610-178a555c041-19dd-4f76-8899-a835254158f612019-01-24
71610-178-45EA - Each71610-178088eedb4-7977-40c6-b8e5-dfc26f837cd412019-01-24
71610-178-53EA - Each71610-17802dc08af-7efe-42b7-8987-97ade20944dd12019-01-24
71610-178-60EA - Each71610-1785feca374-8ded-4f6a-8567-046be8925aee12019-01-24
71610-178-70EA - Each71610-178e49158b4-9234-4d99-a73b-cff0b0ddb47112019-01-24
71610-178-80EA - Each71610-178aab4bc56-e66f-4805-8d44-999d0f970dca12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-178LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20181110_08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197902LORazepam 2 MG Oral TabletPSN08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f751
197902lorazepam 2 MG Oral TabletSCD08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-178-157161001781515 TABLET in 1 BOTTLE (71610-178-15) 15 tablet2018-10-240000-00-00NoNoCurrent
71610-178-307161001783030 TABLET in 1 BOTTLE (71610-178-30) 30 tablet2018-10-240000-00-00NoNoCurrent
71610-178-457161001784545 TABLET in 1 BOTTLE (71610-178-45) 45 tablet2018-10-240000-00-00NoNoCurrent
71610-178-537161001785360 TABLET in 1 BOTTLE (71610-178-53) 60 tablet2018-10-240000-00-00NoNoCurrent
71610-178-607161001786090 TABLET in 1 BOTTLE (71610-178-60) 90 tablet2018-10-240000-00-00NoNoCurrent
71610-178-7071610017870120 TABLET in 1 BOTTLE (71610-178-70) 120 tablet2018-10-240000-00-00NoNoCurrent
71610-178-8071610017880180 TABLET in 1 BOTTLE (71610-178-80) 180 tablet2018-10-240000-00-00NoNoCurrent