Olanzapine

Product NDC
58118-0381
11-digit product format
581180381
Labeler code
58118
Product ID
58118-0381_ebc84746-7764-38a8-e053-2995a90ae36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA204319
Marketing category
ANDA
Marketing start
2019-10-10
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0381-82024-01-30C16284748780-11030e365-0e6c-111a-e063-dadaa90a10e21c3abd7f-115a-4660-b981-d937744437ff

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0381OLANZAPINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20221027_1c3abd7f-115a-4660-b981-d937744437ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0381-85811803810830 TABLET in 1 BLISTER PACK (58118-0381-8) 30 tablet2019-10-100000-00-00NoNoCurrent