FDA.reportPublic FDA data

Lorazepam

Product NDC
71610-199
11-digit product format
716100199
Labeler code
71610
Product ID
71610-199_adbae6b7-14fd-4ce0-a7eb-2154805a2a16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
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
71610-199-10Lorazepam10 in 1 BOTTLETABLET102
71610-199-15Lorazepam15 in 1 BOTTLETABLET152
71610-199-20Lorazepam20 in 1 BOTTLETABLET202
71610-199-30Lorazepam30 in 1 BOTTLETABLET302
71610-199-45Lorazepam45 in 1 BOTTLETABLET452
71610-199-53Lorazepam60 in 1 BOTTLETABLET602
71610-199-55Lorazepam75 in 1 BOTTLETABLET752
71610-199-60Lorazepam90 in 1 BOTTLETABLET902
71610-199-70Lorazepam120 in 1 BOTTLETABLET1202
71610-199-75Lorazepam150 in 1 BOTTLETABLET1502
71610-199-80Lorazepam180 in 1 BOTTLETABLET1802
71610-199-92Lorazepam270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-199-10EA - Each71610-199a0efd14c-a000-49b0-b0c9-20e952c47ee812019-02-13
71610-199-15EA - Each71610-199eb131d7d-cd61-45af-b9f2-d9f9e9131c5d12019-02-13
71610-199-20EA - Each71610-1996c2c3e6e-1994-4a8c-9d68-b0d7c7e9256b12019-02-13
71610-199-30EA - Each71610-19958465786-0772-4c0f-98dd-e763cd03a9da12019-02-13
71610-199-45EA - Each71610-19990453b6b-b300-4bd9-91d3-9ece7b5b19ef12019-02-13
71610-199-53EA - Each71610-199b15dd8d6-7986-4288-808f-d4b091c7736712019-02-13
71610-199-55EA - Each71610-19925860744-0e7e-4ff3-bd64-8aee70b5731112019-02-13
71610-199-60EA - Each71610-1995193c0f5-5920-4bd3-977e-33426bba20b912019-02-13
71610-199-70EA - Each71610-19928ae183b-2dc3-4480-ad96-3a8b94045dad12019-02-13
71610-199-75EA - Each71610-199011829b8-b90e-4708-9f5b-b70502283f5312019-02-13
71610-199-80EA - Each71610-199ac17aa0b-656d-4e2a-8f2d-237958af1dce12019-02-13
71610-199-92EA - Each71610-1995a8d8012-782c-4896-84c1-8198b5fb0b2912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-199LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 12 package rows20190109_a4fa14be-cef1-4b4b-b099-abde92f15145.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNa4fa14be-cef1-4b4b-b099-abde92f151452
197900lorazepam 0.5 MG Oral TabletSCDa4fa14be-cef1-4b4b-b099-abde92f151452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-199-107161001991010 TABLET in 1 BOTTLE (71610-199-10) 10 tablet2018-11-270000-00-00NoNoCurrent
71610-199-157161001991515 TABLET in 1 BOTTLE (71610-199-15) 15 tablet2018-11-270000-00-00NoNoCurrent
71610-199-207161001992020 TABLET in 1 BOTTLE (71610-199-20) 20 tablet2018-11-270000-00-00NoNoCurrent
71610-199-307161001993030 TABLET in 1 BOTTLE (71610-199-30) 30 tablet2018-11-270000-00-00NoNoCurrent
71610-199-457161001994545 TABLET in 1 BOTTLE (71610-199-45) 45 tablet2018-11-270000-00-00NoNoCurrent
71610-199-537161001995360 TABLET in 1 BOTTLE (71610-199-53) 60 tablet2018-11-270000-00-00NoNoCurrent
71610-199-557161001995575 TABLET in 1 BOTTLE (71610-199-55) 75 tablet2018-11-270000-00-00NoNoCurrent
71610-199-607161001996090 TABLET in 1 BOTTLE (71610-199-60) 90 tablet2018-11-270000-00-00NoNoCurrent
71610-199-7071610019970120 TABLET in 1 BOTTLE (71610-199-70) 120 tablet2018-11-270000-00-00NoNoCurrent
71610-199-7571610019975150 TABLET in 1 BOTTLE (71610-199-75) 150 tablet2018-11-270000-00-00NoNoCurrent
71610-199-8071610019980180 TABLET in 1 BOTTLE (71610-199-80) 180 tablet2018-11-270000-00-00NoNoCurrent
71610-199-9271610019992270 TABLET in 1 BOTTLE (71610-199-92) 270 tablet2018-11-270000-00-00NoNoCurrent