FDA.reportPublic FDA data

Olanzapine

Product NDC
50090-3081
11-digit product format
500903081
Labeler code
50090
Product ID
50090-3081_f215247d-8582-4ff4-969b-b50f7872be16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3081-02020-01-31C16284748780-19d75b9cf-cf50-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3081-0Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED107
50090-3081-0Olanzapine10 in 1 CARTONTABLET, FILM COATED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3081-0EA - Each50090-3081bf42e1dc-9b54-46bd-818f-6abd618b6c8212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3081OLANZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20180607_f8bee685-7187-4edb-8865-07128035454e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNf8bee685-7187-4edb-8865-07128035454e7
312078OLANZapine 5 MG Oral TabletPSNf8bee685-7187-4edb-8865-07128035454e7
314154olanzapine 10 MG Oral TabletSCDf8bee685-7187-4edb-8865-07128035454e7
312078olanzapine 5 MG Oral TabletSCDf8bee685-7187-4edb-8865-07128035454e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3081-05009030810010 in 1 BLISTER PACKHistorical