Olanzapine

Product NDC
72189-478
11-digit product format
721890478
Labeler code
72189
Product ID
72189-478_2c4e094c-5799-f564-e063-6294a90ac3f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202862
Marketing category
ANDA
Marketing start
2023-05-30
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

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
72189-478-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-478-30EA - Each72189-4787379bdcc-165b-4592-bab3-5c6a4bcf5a4d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-478OLANZAPINE TABLET, FILM COATED [DIRECT_RX]2Current NDC, 1 package rows20250123_fcec190f-b865-c5d3-e053-6394a90a7e45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200034OLANZapine 2.5 MG Oral TabletPSNfcec190f-b865-c5d3-e053-6394a90a7e452
200034olanzapine 2.5 MG Oral TabletSCDfcec190f-b865-c5d3-e053-6394a90a7e452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-478-307218904783030 TABLET, FILM COATED in 1 BOTTLE (72189-478-30) 2023-05-30NoNoHistorical