Olanzapine

Product NDC
68084-525
11-digit product format
680840525
Labeler code
68084
Product ID
68084-525_4198cdd2-0af7-d4da-e063-6394a90a4142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076255
Marketing category
ANDA
Marketing start
2012-05-01
Substance
OLANZAPINE
Active strength
2.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 312078, 314154

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-525-01Olanzapine100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10012
68084-525-11Olanzapine1 in 1 BLISTER PACKTABLET, FILM COATED112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-525OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20240605_75616c31-8fed-4014-a9f2-4a028eccd586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN75616c31-8fed-4014-a9f2-4a028eccd58612
200034OLANZapine 2.5 MG Oral TabletPSN75616c31-8fed-4014-a9f2-4a028eccd58612
312078OLANZapine 5 MG Oral TabletPSN75616c31-8fed-4014-a9f2-4a028eccd58612
314154olanzapine 10 MG Oral TabletSCD75616c31-8fed-4014-a9f2-4a028eccd58612
200034olanzapine 2.5 MG Oral TabletSCD75616c31-8fed-4014-a9f2-4a028eccd58612
312078olanzapine 5 MG Oral TabletSCD75616c31-8fed-4014-a9f2-4a028eccd58612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-525-0168084052501100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-525-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-525-11) 100 blister pack2012-05-010000-00-00NoNoCurrent
68084-525-11680840525111 in 1 BLISTER PACKHistorical