Olanzapine

Product NDC
0832-6079
11-digit product format
008326079
Labeler code
0832
Product ID
0832-6079_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA204319
Marketing category
ANDA
Marketing start
2016-01-27
Marketing end
2026-08-31
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE5 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
0832-6079-03Olanzapine30 in 1 BOTTLETABLET302
0832-6079-50Olanzapine500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6079OLANZAPINE TABLET [UPSHER-SMITH LABORATORIES, LLC]1Current NDC, 2 package rows20240807_dbe23f33-9e7d-49a7-8528-fa290661a96f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
312077OLANZapine 15 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
200034OLANZapine 2.5 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
283639OLANZapine 20 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
312078OLANZapine 5 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
312079OLANZapine 7.5 MG Oral TabletPSNdbe23f33-9e7d-49a7-8528-fa290661a96f2
314154olanzapine 10 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2
312077olanzapine 15 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2
200034olanzapine 2.5 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2
283639olanzapine 20 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2
312078olanzapine 5 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2
312079olanzapine 7.5 MG Oral TabletSCDdbe23f33-9e7d-49a7-8528-fa290661a96f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-6079-030083260790330 TABLET in 1 BOTTLE (0832-6079-03) 30 tablet2024-08-152026-08-31NoNoHistorical
0832-6079-5000832607950500 TABLET in 1 BOTTLE (0832-6079-50) 500 tablet2024-08-152026-08-31NoNoHistorical