Olanzapine

Product NDC
50090-3958
11-digit product format
500903958
Labeler code
50090
Product ID
50090-3958_77d3d923-8571-4523-8e69-234ebeb7a5fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078109
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3958-0Olanzapine1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING16
50090-3958-0Olanzapine28 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3958-0EA - Each50090-3958f94ed3ee-238e-4808-84a3-11c865d4a8bf12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3958OLANZAPINE TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210617_8ff9fc66-8367-445b-bb35-f6b112543d36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN8ff9fc66-8367-445b-bb35-f6b112543d366
312076olanzapine 10 MG Disintegrating Oral TabletSCD8ff9fc66-8367-445b-bb35-f6b112543d366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3958-0500903958001 BOX, UNIT-DOSE in 1 BLISTER PACK (50090-3958-0) > 28 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE2018-12-120000-00-00NoNoCurrent