FDA.reportPublic FDA data

Olanzapine

Product NDC
72241-054
11-digit product format
722410054
Labeler code
72241
Product ID
72241-054_46c3d805-c651-4086-ae20-b6ef6788b840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA210022
Marketing category
ANDA
Marketing start
2023-02-27
Substance
OLANZAPINE
Active strength
10 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
OLANZAPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312077, 312078, 312079, 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
72241-054-05Olanzapine100 in 1 BOTTLETABLET1003
72241-054-10Olanzapine500 in 1 BOTTLETABLET5003
72241-054-11Olanzapine1000 in 1 BOTTLETABLET10003
72241-054-22Olanzapine30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-054-22EA - Each72241-0548a04659d-0d0c-4159-b379-ee6b3fa191b012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-054OLANZAPINE TABLET [MODAVAR PHARMACEUTICALS LLC]3Current NDC, 4 package rows20250408_f0943b4e-6bdc-48c1-8ecd-39cf732e16f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312077OLANZapine 15 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
200034OLANZapine 2.5 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
283639OLANZapine 20 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312078OLANZapine 5 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312079OLANZapine 7.5 MG Oral TabletPSNf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
314154olanzapine 10 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312077olanzapine 15 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
200034olanzapine 2.5 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
283639olanzapine 20 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312078olanzapine 5 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
312079olanzapine 7.5 MG Oral TabletSCDf0943b4e-6bdc-48c1-8ecd-39cf732e16f53
314154OLANZapine 10 MG Oral TabletPSN3ed78a7d-4014-d280-e063-6294a90a8ee91
314154olanzapine 10 MG Oral TabletSCD3ed78a7d-4014-d280-e063-6294a90a8ee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72241-054-0572241005405100 TABLET in 1 BOTTLE (72241-054-05) 100 tablet2024-01-17NoNoCurrent
72241-054-1072241005410500 TABLET in 1 BOTTLE (72241-054-10) 500 tablet2024-01-17NoNoCurrent
72241-054-11722410054111000 TABLET in 1 BOTTLE (72241-054-11) 1000 tablet2024-01-17NoNoCurrent
72241-054-227224100542230 TABLET in 1 BOTTLE (72241-054-22) 30 tablet2024-01-17NoNoCurrent