FDA.reportPublic FDA data

Lorazepam

Product NDC
50090-5508
11-digit product format
500905508
Labeler code
50090
Product ID
50090-5508_a0cf0a66-bac8-4a9a-abf6-809635b3f84f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078203
Marketing category
ANDA
Marketing start
2023-05-16
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197901

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5508-02023-02-06C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5508-12023-02-06C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5508-22023-02-06C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5508-02023-01-30C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5508-12023-01-30C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
50090-5508-22023-01-30C16284748780-1f386c649-cc7c-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5508-0Lorazepam30 in 1 BOTTLETABLET309
50090-5508-1Lorazepam100 in 1 BOTTLETABLET1009
50090-5508-2Lorazepam60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5508-0EA - Each50090-5508b2d8d933-6098-4d4f-8966-dc91477f222312024-12-10
50090-5508-1EA - Each50090-55087dbc1326-21c0-4da0-9db8-4829848c61c612024-12-10
50090-5508-2EA - Each50090-55083b7d0a63-e8bc-476b-8765-f77e8e269a9812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5508LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20241115_8361519b-be1a-4542-a782-d7cdfa153e86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN8361519b-be1a-4542-a782-d7cdfa153e869
197901lorazepam 1 MG Oral TabletSCD8361519b-be1a-4542-a782-d7cdfa153e869

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5508-05009055080030 TABLET in 1 BOTTLE (50090-5508-0) 30 tablet2023-05-160000-00-00NoNoCurrent
50090-5508-150090550801100 TABLET in 1 BOTTLE (50090-5508-1) 100 tablet2023-05-160000-00-00NoNoCurrent
50090-5508-25009055080260 TABLET in 1 BOTTLE (50090-5508-2) 60 tablet2023-05-160000-00-00NoNoCurrent