Olanzapine

Product NDC
65862-565
11-digit product format
658620565
Labeler code
65862
Product ID
65862-565_e10b90de-4a0a-413e-a5f9-6978a183b568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202050
Marketing category
ANDA
Marketing start
2012-04-23
Substance
OLANZAPINE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE15 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
65862-565-01Olanzapine100 in 1 BOTTLETABLET10021
65862-565-10Olanzapine10 in 1 BLISTER PACKTABLET1021
65862-565-10Olanzapine10 in 1 CARTONTABLET1021
65862-565-30Olanzapine30 in 1 BOTTLETABLET3021
65862-565-99Olanzapine1000 in 1 BOTTLETABLET100021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-565OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 5 package rows20250306_636665be-9d7e-443a-8134-e8cc47e6ba24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
312077OLANZapine 15 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
200034OLANZapine 2.5 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
283639OLANZapine 20 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
312078OLANZapine 5 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
312079OLANZapine 7.5 MG Oral TabletPSN636665be-9d7e-443a-8134-e8cc47e6ba2421
314154olanzapine 10 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421
312077olanzapine 15 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421
200034olanzapine 2.5 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421
283639olanzapine 20 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421
312078olanzapine 5 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421
312079olanzapine 7.5 MG Oral TabletSCD636665be-9d7e-443a-8134-e8cc47e6ba2421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-565-0165862056501100 TABLET in 1 BOTTLE (65862-565-01) 100 tablet2012-04-230000-00-00NoNoCurrent
65862-565-106586205651010 BLISTER PACK in 1 CARTON (65862-565-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent
65862-565-306586205653030 TABLET in 1 BOTTLE (65862-565-30) 30 tablet2012-04-230000-00-00NoNoCurrent
65862-565-71658620565717000 TABLET in 1 BAG (65862-565-71)7000 tablet23-APR-12Current
65862-565-99658620565991000 TABLET in 1 BOTTLE (65862-565-99) 1000 tablet2012-04-230000-00-00NoNoCurrent