FDA.reportPublic FDA data

Olanzapine

Product NDC
60505-3278
11-digit product format
605053278
Labeler code
60505
Product ID
60505-3278_997c6776-1ac1-bcb1-022c-2c5b6c277395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA091265
Marketing category
ANDA
Marketing start
2011-10-24
Substance
OLANZAPINE
Active strength
20 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
OLANZAPINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312076, 314155, 351107, 351108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3278-0Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1019
60505-3278-0Olanzapine10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1019
60505-3278-3Olanzapine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3019
60505-3278-8Olanzapine1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3278-0EA - Each60505-3278fe705f6f-81a5-4cd4-8414-4fa6fa09939512012-07-24
60505-3278-3EA - Each60505-3278d652e3f1-35dc-4ddf-bc98-29e2a6eeb02812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
Carboxymethylcellulose CalciumINACTIVE INGREDIENTUTY7PDF93LOLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4OLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3278OLANZAPINE TABLET, ORALLY DISINTEGRATING [APOTEX CORP.]19Current NDC, Legacy NDC, 4 package rows20250411_96165590-b287-0ed9-3723-752af59aedad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351108OLANZapine 20 MG Disintegrating Oral TabletPSN58f175a8-5549-4f9e-baf4-8dc340c2cfd5106
351108olanzapine 20 MG Disintegrating Oral TabletSCD58f175a8-5549-4f9e-baf4-8dc340c2cfd5106
312076OLANZapine 10 MG Disintegrating Oral TabletPSN96165590-b287-0ed9-3723-752af59aedad19
351107OLANZapine 15 MG Disintegrating Oral TabletPSN96165590-b287-0ed9-3723-752af59aedad19
351108OLANZapine 20 MG Disintegrating Oral TabletPSN96165590-b287-0ed9-3723-752af59aedad19
314155OLANZapine 5 MG Disintegrating Oral TabletPSN96165590-b287-0ed9-3723-752af59aedad19
312076olanzapine 10 MG Disintegrating Oral TabletSCD96165590-b287-0ed9-3723-752af59aedad19
351107olanzapine 15 MG Disintegrating Oral TabletSCD96165590-b287-0ed9-3723-752af59aedad19
351108olanzapine 20 MG Disintegrating Oral TabletSCD96165590-b287-0ed9-3723-752af59aedad19
314155olanzapine 5 MG Disintegrating Oral TabletSCD96165590-b287-0ed9-3723-752af59aedad19
312076OLANZapine 10 MG Disintegrating Oral TabletPSN9847a0e4-24fc-f4e8-e053-2995a90a961e9
351107OLANZapine 15 MG Disintegrating Oral TabletPSN9847a0e4-24fc-f4e8-e053-2995a90a961e9
351108OLANZapine 20 MG Disintegrating Oral TabletPSN9847a0e4-24fc-f4e8-e053-2995a90a961e9
314155OLANZapine 5 MG Disintegrating Oral TabletPSN9847a0e4-24fc-f4e8-e053-2995a90a961e9
312076olanzapine 10 MG Disintegrating Oral TabletSCD9847a0e4-24fc-f4e8-e053-2995a90a961e9
351107olanzapine 15 MG Disintegrating Oral TabletSCD9847a0e4-24fc-f4e8-e053-2995a90a961e9
351108olanzapine 20 MG Disintegrating Oral TabletSCD9847a0e4-24fc-f4e8-e053-2995a90a961e9
314155olanzapine 5 MG Disintegrating Oral TabletSCD9847a0e4-24fc-f4e8-e053-2995a90a961e9
351108OLANZapine 20 MG Disintegrating Oral TabletPSN1e046c66-4d54-33b0-e063-6394a90a178a1
351108olanzapine 20 MG Disintegrating Oral TabletSCD1e046c66-4d54-33b0-e063-6394a90a178a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3278-06050532780010 BLISTER PACK in 1 CARTON (60505-3278-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2011-10-240000-00-00NoNoCurrent
60505-3278-36050532780330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3278-3) 2011-10-240000-00-00NoNoCurrent
60505-3278-8605053278081000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3278-8) 2011-10-240000-00-00NoNoCurrent