Lorazepam

Product NDC
71610-225
11-digit product format
716100225
Labeler code
71610
Product ID
71610-225_15ea852c-5478-544b-e063-6394a90a1ac5
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
2023-05-16
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

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
71610-225-10Lorazepam10 in 1 BOTTLETABLET104
71610-225-15Lorazepam15 in 1 BOTTLETABLET154
71610-225-20Lorazepam20 in 1 BOTTLETABLET204
71610-225-28Lorazepam28 in 1 BOTTLETABLET284
71610-225-30Lorazepam30 in 1 BOTTLETABLET304
71610-225-45Lorazepam45 in 1 BOTTLETABLET454
71610-225-53Lorazepam60 in 1 BOTTLETABLET604
71610-225-60Lorazepam90 in 1 BOTTLETABLET904
71610-225-70Lorazepam120 in 1 BOTTLETABLET1204
71610-225-75Lorazepam150 in 1 BOTTLETABLET1504
71610-225-80Lorazepam180 in 1 BOTTLETABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-225-10EA - Each71610-22590e98cbd-61d7-4e04-b840-a60b4bee03d212024-01-04
71610-225-15EA - Each71610-225f2813b03-d70c-43cb-ab09-548a1b54aef712019-02-13
71610-225-20EA - Each71610-22515cb665e-7d44-4a1f-92a8-e5838a66b97912024-01-04
71610-225-28EA - Each71610-22541892146-bb28-4cc0-9448-038d4ee6190612024-06-10
71610-225-30EA - Each71610-225e29570f7-dffe-480c-974b-e90e6479ad0512019-02-13
71610-225-45EA - Each71610-2255ed5e1d3-c5a4-46a6-8988-3305948f7d8c12024-01-04
71610-225-53EA - Each71610-225b0dfab47-db44-4fd5-aac7-02fe3c913eae12019-02-13
71610-225-60EA - Each71610-2251053b298-28b0-496d-b7ef-578ce813a31212019-02-13
71610-225-70EA - Each71610-22511e35801-a5bc-4a07-a188-864ec9f91ac112023-08-08
71610-225-80EA - Each71610-22543afadf0-dc10-4c9d-aa08-dd3fbfde62f312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-225LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 11 package rows20240418_e563594e-212c-4f31-92ea-294aeab45df3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNe563594e-212c-4f31-92ea-294aeab45df34
197900lorazepam 0.5 MG Oral TabletSCDe563594e-212c-4f31-92ea-294aeab45df34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-225-107161002251010 TABLET in 1 BOTTLE (71610-225-10) 10 tablet2023-11-02NoNoHistorical
71610-225-157161002251515 TABLET in 1 BOTTLE (71610-225-15) 15 tablet2023-05-160000-00-00NoNoCurrent
71610-225-207161002252020 TABLET in 1 BOTTLE (71610-225-20) 20 tablet2023-11-02NoNoHistorical
71610-225-287161002252828 TABLET in 1 BOTTLE (71610-225-28) 28 tablet2024-04-12NoNoHistorical
71610-225-307161002253030 TABLET in 1 BOTTLE (71610-225-30) 30 tablet2023-05-160000-00-00NoNoCurrent
71610-225-457161002254545 TABLET in 1 BOTTLE (71610-225-45) 45 tablet2023-05-16NoNoHistorical
71610-225-537161002255360 TABLET in 1 BOTTLE (71610-225-53) 60 tablet2023-05-160000-00-00NoNoCurrent
71610-225-607161002256090 TABLET in 1 BOTTLE (71610-225-60) 90 tablet2023-05-160000-00-00NoNoCurrent
71610-225-7071610022570120 TABLET in 1 BOTTLE (71610-225-70) 120 tablet2023-06-19NoNoHistorical
71610-225-7571610022575150 TABLET in 1 BOTTLE (71610-225-75) 150 tablet2023-06-19NoNoHistorical
71610-225-8071610022580180 TABLET in 1 BOTTLE (71610-225-80) 180 tablet2023-05-160000-00-00NoNoCurrent