Lorazepam

Product NDC
71610-768
11-digit product format
716100768
Labeler code
71610
Product ID
71610-768_0ce251c7-bba3-45c9-aa24-6b7c6007b13a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076045
Marketing category
ANDA
Marketing start
2023-06-25
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
O26FZP769LLORAZEPAM846-49-1LORAZEPAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-768-307161007683030 TABLET in 1 BOTTLE (71610-768-30) 30 tablet2024-02-05NoNoHistorical
71610-768-537161007685360 TABLET in 1 BOTTLE (71610-768-53) 60 tablet2024-01-09NoNoHistorical
71610-768-607161007686090 TABLET in 1 BOTTLE (71610-768-60) 90 tablet2024-02-05NoNoHistorical
71610-768-7071610076870120 TABLET in 1 BOTTLE (71610-768-70) 120 tablet2024-01-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lorazepam Tablets, USP CIVAphena Pharma Solutions - Tennessee, LLC2024-02-06HUMAN PRESCRIPTION DRUG LABEL3